GHS Classification Results by the Japanese Government

Japanese



GENERAL INFORMATION
Item Information
CAS RN 85535-85-9
Chemical Name Chlorinated paraffin (C=14-17)
Substance ID R03-A-016-METI, MOE
Classification year (FY) FY2021
Ministry who conducted the classification Ministry of Economy, Trade and Industry (METI)/Ministry of the Environment (MOE)
New/Revised New
Classification result in other fiscal year  
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
UN GHS document (External link) UN GHS document
Definitions/Abbreviations (Excel file) Definitions/Abbreviations
Model Label by MHLW (External link)  
Model SDS by MHLW (External link)  
OECD/eChemPortal (External link) eChemPortal

PHYSICAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Explosives Not classified (Not applicable)
-
-
- - There are no chemical groups associated with explosive properties present in the molecule.
2 Flammable gases Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
3 Aerosols Not classified (Not applicable)
-
-
- - Not aerosol products.
4 Oxidizing gases Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
5 Gases under pressure Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
6 Flammable liquids Not classified
-
-
- - It was classified as "Not classified" from information that it is not combustible (REACH (Accessed May 2021)).
7 Flammable solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
8 Self-reactive substances and mixtures Not classified (Not applicable)
-
-
- - There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9 Pyrophoric liquids Not classified
-
-
- - It was classified as "Not classified" from information that it is not combustible (REACH (Accessed May 2021)).
10 Pyrophoric solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
11 Self-heating substances and mixtures Not classified
-
-
- - It was classified as "Not classified" from information that it is not combustible (REACH (Accessed May 2021)).
12 Substances and mixtures which, in contact with water, emit flammable gases Not classified (Not applicable)
-
-
- - The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13 Oxidizing liquids Not classified (Not applicable)
-
-
- - The substance is an organic compound containing chlorine (but not fluorine or oxygen) which is chemically bonded only to carbon or hydrogen.
14 Oxidizing solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
15 Organic peroxides Not classified (Not applicable)
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule.
16 Corrosive to metals Classification not possible
-
-
- - No data available.
17 Desensitized explosives Not classified (Not applicable)
-
-
- - There are no chemical groups associated with explosive properties present in the molecule.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Not classified
-
-
- - [Rationale for the Classification]
Based on (1) to (2), it was classified as "Not classified."

[Evidence Data]
(1) LD50 for rats: > 15,000 mg/kg (EFSA (2019), REACH registration dossier (Accessed May 2021))
(2) LD50 for rats: > 4,000 mg/kg (EFSA (2019), AICIS IMAP (2015))
1 Acute toxicity (Dermal) Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Gases) Not classified
-
-
- - [Rationale for the Classification]
Liquid (GHS definition). It was classified as "Not classified."
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
2 Skin corrosion/irritation Not classified
-
-
- - [Rationale for the Classification]
Based on (1) and (2), it was classified as "Not classified" (Category 3 in UN GHS classification).

[Evidence Data]
(1) It was reported that, in an acute dermal irritation/corrosion test with rabbits (n=6) (OECD TG 404, occlusive, 4-hour application, observation for 14 days) for this substance (40% chlorination), drying and hardness of the skin were observed in advence at 72 hours, peeling of the outer-most skin layer 6 to 8 days and scales were seen on the skin 6 to 10 days after application (mean erythema score at 24/48/72h after application: 1.5, mean edema score: 0.6) (AICIS IMAP (2015), REACH registration dossier (Accessed May 2021)).
(2) It was reported that, in an acute dermal irritation/corrosion test with rabbits (n=6) (OECD TG 404, occlusive, 4-hour application, observation for 14 days) for this substance (52% chlorination), scales were seen on the skin 6 to 10 days after application (mean erythema score at 24/48/72h after application: 1.3, mean edema score: 0.3) (AICIS IMAP (2015), REACH registration dossier (Accessed May 2021)).
3 Serious eye damage/eye irritation Not classified
-
-
- - [Rationale for the Classification]
Based on (1) to (3), it was classified as "Not classified."

[Evidence Data]
(1) It was reported that, in an eye irritation test with rabbits (n=3) for this substance (40% and 45% chlorination), slight conjunctival irritation was observed at 1 to 2 hours after application in all cases (AICIS IMAP (2015), REACH registration dossier (Accessed May 2021)).
(2) It was reported that, in an acute eye irritation/corrosion test with rabbits (n=3) (OECD TG 405, observation for 48 hours) for this substance (52% chlorination), mild conjunctival redness was observed in one case until 48 hours after application (AICIS IMAP (2015), REACH registration dossier (Accessed May 2021)).
(3) It was reported that, in an acute eye irritation/corrosion test with rabbits (n=3) (OECD TG 405, observation for 48 hours) for this substance (40% and 45% chlorination), mild conjunctival redness was observed in one case until 48 hours after application (AICIS IMAP (2015), REACH registration dossier (Accessed May 2021)).
4 Respiratory sensitization Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
4 Skin sensitization Not classified
-
-
- - [Rationale for the Classification]
Based on (1) and (2), it was classified as "Not classified."

[Evidence Data]
(1) It was reported that, in a maximization test with guinea pigs (n=20) (intradermal injection: 20% solution) for this substance (40% chlorination), the positive rate at 48 hours after the challenge was 5% (1/10 cases) and the second challenge using the undiluted solution did not result in positive skin reactions (AICIS IMAP (2015), REACH registration dossier (Accessed May 2021)).
(2) It was reported that, in a maximization test with guinea pigs (intradermal injection: 5% solution) for this substance (40% and 45% chlorination), no positive reactions were observed at 24 or 48 hours after the challenge (AICIS IMAP (2015), REACH registration dossier (Accessed May 2021)).
5 Germ cell mutagenicity Not classified
-
-
- - [Rationale for the Classification]
Based on (1) to (4), it was classified as "Not classified."

[Evidence Data]
(1) In a mammalian erythrocyte micronucleus test (OECD TG474, GLP, 42% and 45% chlorination) using the bone marrow cells of mice, negative results were reported (EFSA (2019), AICIS IMAP (2015), REACH registration dossier (Accessed May 2021)).
(2) In a mammalian bone marrow chromosomal aberration test (OECD TG475, GLP, 52% chlorination) using the bone marrow cells of rats, negative results were reported (EFSA (2019), AICIS IMAP (2015), REACH registration dossier (Accessed May 2021)).
(3) In a bacterial reverse mutation test (equivalent to OECD TG471, 42% chlorination), negative results were reported (EFSA (2019), AICIS IMAP (2015), REACH registration dossier (Accessed May 2021)).
(4) The view that comprehensively judging from the results from the available studies, genotoxicity of this substance is negative has been presented (EFSA (2019), AICIS IMAP (2015)).
6 Carcinogenicity Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
7 Reproductive toxicity Category 1B, Additional category for effects on or via lactation


Danger
H360 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
Based on (1) to (3), it was classified in Category 1B, and effects on lactation were added. Besides, in (1), at a dose at which no general toxicity effects were observed in parental animals, reduced survival rate and subcutaneous hematoma/hemorrhage were observed in pups. In (2) and (3), it was suggested that this substance or a metabolite was transferred to pups via breast milk in the lactation period after birth and blood clotting disturbance occurred, causing hemorrhagic tendency, internal hemorrhaging, and death.

[Evidence Data]
(1) It was reported that, in a one-generation reproduction toxicity study with rats dosed by feeding, reduced survival rate and subcutaneous hematoma/hemorrhage were observed in pups at or above 90 mg/kg/day (EFSA (2019), AICIS IMAP (2015)).
(2) In the two groups, one group in which female rats were dosed (6,250 ppm: 560 mg/kg/day) during the gestation period and also dosed similarly during the lactation period, and the other group in which female rats were dosed during the gestation period and then the pups born from the control group were fed diets containing this substance at 6,250 ppm, the increased mortality of F1 pups (67% and 77%) and the increased incidence of internal hemorrhaging (8% and 17%) were observed, compared to the group of pups born from and reared by dams which were fed control diets throughout the gestation and lactation periods, and the group of pups born from the treated group and reared by dams in the control group. In the pups of these groups, a decrease in the concentration of clotting factor X in blood was observed, and it was suggested that this substance or a metabolite transferred via milk impaired the vitamin K dependent clotting system in the pups, or decreased vitamin K in the breast milk, causing clotting disturbance in pups (EFSA (2019), AICIS IMAP (2015)).
(3) In rats, medium-chain chlorinated paraffins (MCCPs) perturbed the clotting system in lactating neonates of treated mothers. The hemorrhagic effects in lactating neonates appeared as a result of persistent vitamin K deficiency, and the EFSA's expert panel concluded that this phenomenon was also relevant to humans (EFSA (2019)).

[Reference Data, etc.]
(4) It was reported that, in a prenatal development toxicity study (OECD TG 414, days 6-19 of gestation) with rats dosed by gavage, no developmental toxicity was observed (EFSA (2019), AICIS IMAP (2015)).
(5) It was reported that, in a prenatal development toxicity study (OECD TG 414, days 6-27 of gestation) with rabbits dosed by gavage, no developmental toxicity was observed. (EFSA (2019), AICIS IMAP (2015)).
(6) It was reported that, in a reproduction/developmental toxicity screening test (equivalent to OECD TG421, from 28 days before mating until day 21 of lactation) with rats dosed by feeding, no reproductive toxicity was observed (EFSA (2019), AICIS IMAP (2015)).
(7) Medium-chain chlorinated paraffins (MCCPs) were detectable in 25 human milk samples of 18 women from London and Lancaster, the U.K. The values varied from 6.2 to 320 ng/g fat, with a median concentration of 21 ng/g fat and a 97.5th percentile of 130.9 ng/g fat, and no difference was seen between samples obtained from women in Lancaster or London (REACH registration dossier (Accessed May 2021)).
(8) Detectable levels of this substance were found in one (61 ng/g fat) of 22 human milk samples collected anonymously (REACH registration dossier (Accessed May 2021)).
(9) In the EU, it was classified in Lact. (Classification in CLP (Accessed May 2021)).
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
9 Specific target organ toxicity - Repeated exposure Category 1 (kidney, thyroid)


Danger
H372 P260
P264
P270
P314
P501
[Rationale for the Classification]
Based on (1) to (3), it was classified in Category 1 (kidney, thyroid). Besides, since the effects on the liver were considered to be adaptive drug responses, they were not adopted.

[Evidence Data]
(1) It was reported that, in a 90-day oral toxicity study with rats dosed by feeding, an increase in serum cholesterol and effects on the thyroid (reduced follicle sizes, tissue destruction, increased follicle height, nuclear vesiculation) were observed in females at 3.6 mg/kg/day (males, within the range for Category 1) and 4.2 mg/kg/day (females, within the range for Category 1); anisokaryosis and vesiculation of hepatocytes in males and females, effects on the thyroid (cytoplasmic vacuolation in males and females and reduced follicle sizes, tissue destruction, increased follicle height and nuclear vesiculation in males), and effects on the liver (an increase in relative liver weight, perivenous hepatocyte homogeneity), and inner medullary tubular dilation in females were observed at 36.2 mg/kg/day (males, within the range for Category 2) and 42.2 mg/kg/day (females, within the range for Category 2). However, it was reported that, since there was no test-based analysis and description on the liver, kidney, and thyroid, histopathological interpretation was not possible (EFSA (2019)).
(2) It was reported that, in a 90-day oral toxicity study with rats dosed by feeding, chronic nephritis was observed in males and females at 10 mg/kg/day (males, within the range for Category 1); and increases in absolute and relative liver and kidney weight in males and females and an increase in serum cholesterol in females were observed at 100 mg/kg/day (within the range for Category 2) (EFSA (2019)).
(3) It was reported that, in a 90-day oral toxicity study with rats dosed by feeding, increased hepatic UDPGT activity was observed in females at 100 ppm (9.3 mg/kg/day (males), 9.7 mg/kg/day (females), within the range for Category 1); and a decrease in plasma FT3 levels in males and an increase in plasma TSH levels and thyroiditis in females were observed at 300 ppm (23 mg/kg/day (males), 24.6 mg/kg/day (females), within the range for Category 2) (EFSA (2019), AICIS IMAP (2015), REACH registration dossier (Accessed May 2021)).
10 Aspiration hazard Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.

ENVIRONMENTAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
11 Hazardous to the aquatic environment Short term (Acute) Category 1


Warning
H400 P273
P391
P501
It was classified in Category 1 from 48-hour EC50 = 0.0059 mg/L for crustacea (Daphnia magna) (EU REACH CoRAP, 2019, EU REACH SVHC, 2021).
11 Hazardous to the aquatic environment Long term (Chronic) Category 1


Warning
H410 P273
P391
P501
Sufficient data on rapid degradability were not obtained. It was classified in Category 1 from 21-day NOEC = 0.0087 mg/L for crustacea (Daphnia magna) (EU REACH CoRAP, 2019, EU REACH SVHC, 2021).
12 Hazardous to the ozone layer Classification not possible
-
-
- - This substance is not listed in the Annexes to the Montreal Protocol.


NOTE:
  • GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
  • Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
  • This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
  • Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
  • A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
  • An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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