Reaction mass of carbon tetrachloride and chloroform and 1,2-dichloroethane

Endpoint summary

Description of key information

Skin sensitiser based on the rules of the CLP Regulation for classification of mixtures

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Reference 1

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Compliant to GLP and testing guideline; adequate coherence between data, comments and conclusions.

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Breeder: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: approximately 9 weeks old
- Weight at study initiation: 20.8 ± 0.7 g
- Housing: housed individually in disposable crystal polystyrene cages (22.00 cm x 8.50 cm x 8.00 cm). Each cage contained (except for the 5 hours following the 3H-TdR injections) autoclaved sawdust (SICSA, Alfortville, France)
- Diet (e.g. ad libitum): conventional laboratory diet (SSNIFF R/M-H pelleted maintenance diet)
- Water (e.g. ad libitum): tap water (filtered using a 0.22 micron filter)
- Acclimation period: at least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 12 cycles/hour
- Photoperiod (hrs dark / hrs light): 12 h/12 h (7:00 - 19:00)

IN-LIFE DATES: From 23 February 2010 to 08 March 2010

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

25, 50 and 100%.

No. of animals per dose:

4 animals.

Details on study design:

RANGE FINDING TESTS:
- Compound solubility: soluble in the first recommended vehicle, acetone/olive oil (4/1, v/v). A solution was obtained at the maximum tested concentration of 50%.
- Irritation: non-irritant, whatever the concentration
- Lymph node proliferation response: incorporation of tritiated methyl thymidine

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: SI >= 3 with exclusion of excessive irritation

TREATMENT PREPARATION AND ADMINISTRATION:
On days 1, 2 and 3, a dose-volume of 25 µL of the control or dosage form preparations was applied to the dorsal surface of both ears, using an adjustable pipette fitted with a plastic tip.

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Positive control results:

HCA at the concentration of 25%: a moderate increase in cellularity and a stimulation index exceeding the threshold value of 3 (SI = 17.10) were noted. The study was therefore considered valid.

Parameter:

SI

Value:

1.51

Test group / Remarks:

Group 2: test item 25%

Parameter:

SI

Value:

2.39

Test group / Remarks:

Group 3: test item 50%

Parameter:

SI

Value:

6.1

Test group / Remarks:

Group 4: test item 100%

Key result

Parameter:

EC3

Remarks:

(%)

Value:

58

Test group / Remarks:

test item

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: see Remark

Remarks:

Group 1 - vehicle : 532.18 (DPM per group) and 66.52 (DPM per node) Group 2 - test item 25% : 801.13 (DPM per group) and 100.14 (DPM per node) Group 3 - test item 50% : 955.80 (DPM per group) and 159.30 (DPM per node) Group 4 - test item 100% : 3244.26 (DPM per group) and 405.53 (DPM per node)

Interpretation of results:

Category 1B (indication of skin sensitising potential) based on GHS criteria

Conclusions:

Under the experimental conditions of this study, the test item, CARBON TETRACHLORIDE, demonstrated weak dermal sensitization potential in the murine Local Lymph Node Assay.

Executive summary:

The potential of the test item, CARBON TETRACHLORIDE, to induce delayed contact hypersensitivity using the murine Local Lymph Node Assay (LLNA) was evaluated. Evaluation of local irritation was also carried out in parallel.

This study was conducted in compliance with the principles of Good Laboratory Practice Regulations.

Methods

A preliminary test was first performed in order to define the concentrations of test item to be used in the main test.

In the main test, 20 female CBA/J mice were allocated to five groups:

. three treated groups of four animals each receiving the test item at the concentrations of 25%, 50% or 100% in a mixture of acetone/olive oil (4/1; v/v) (vehicle),

. one negative control group of four animals receiving the vehicle,

. one positive control group of four animals receiving the reference item, alpha-hexylcinnamaldehyde (HCA), a moderate sensitizer, at the concentration of 25% the vehicle.

 

During the induction phase, the test item, vehicle or reference item was applied over the ears (25 µL per ear) for 3 consecutive days (days 1, 2 and 3). After 2 days of resting, the proliferation of lymphocytes in the lymph node draining the application site was measured by incorporation of tritiated methyl thymidine (day 6). The obtained values were used to calculate Stimulation Indices (SI).

 

The irritant potential of the test item was assessed in parallel by measurement of ear thickness on days 1, 2, 3 and 6.

Results

The test item was soluble in the first recommended vehicle, acetone/olive oil (4/1, v/v). A solution was obtained at the maximum tested concentration of 50%.

 

Consequently, the concentrations selected for the preliminary test were 10%, 25%, 50% and 100%.

 

Since the test item was non-irritant in the preliminary test, the highest concentration retained for the main test was the maximal practicable concentration (100%).

 

No treatment-related mortality or clinical signs were observed during the main test.

Erythema was noted on day 6 in 1/4 females given 100%. No notable increase in ear thickness was observed in any treated animal.

 

A significant lymphoproliferation was noted in the positive control group given HCA at 25%. The study was therefore considered valid.

A dose-related increase in the SI was noted at all the concentrations and the threshold of 3 was exceeded at the concentration of 100%.

The results are presented in the following table:

 

Treatment	Concentration (%)	Irritation level	Stimulation Index (SI)
Test item	25	non-irritant	1.51
Test item	50	non-irritant	2.39
Test item	100	non-irritant	6.10
HCA	25	-	17.10

 

In the absence of local irritation, the positive lymphoproliferative response observed was attributed to delayed contact hypersensitivity. The EC3 value for the test item, CARBON TETRACHLORIDE, is equal to 58%. Therefore, on the basis of relative skin sensitization potency, the test item was classified as weak sensitizer.

Conclusion

Under the experimental conditions of this study, the test item, CARBON TETRACHLORIDE, (batch No. R864), demonstrated weak dermal sensitization potential in the murine Local Lymph Node Assay and thus is classified skin sensitizer category 1B according to CLP and the GHS.

Reference 2

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Compliant to GLP and testing guideline; adequate coherence between data, comments and conclusions.

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: 9 weeks old for the main test and 11 weeks old for the preliminary test
- Weight at study initiation: 21.2 +/- 0.9 g
- Housing: the animals were housed individually in disposable crystal polystyrene cages (22.00 cm x 8.50 cm x 8.00 cm).
- Diet (e.g. ad libitum): SSNIFF R/M-H pelleted maintenance diet (SSNIFF Spezialdiäten GmbH, Soest, Germany)
- Water (e.g. ad libitum): tap water (filtered usingi a 0.22 µm filter)
- Acclimation period: at least 5 days before the beginning of the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 12 cycles/hour
- Photoperiod (hrs dark / hrs light): 12 h/ 12 h

IN-LIFE DATES: From: 07 April 2010 To: 23 April 2010

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

25, 50 and 100%.

No. of animals per dose:

4 females per dose.

Details on study design:

PRELIMINARY TEST:
- Concentrations: 10, 25, 50 and 100%
- Irritation: no irritation whatever the concentration applied

MAIN STUDY
- Criteria used to consider a positive response: Stimulation Index > 3

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Positive control results:

A significant lymphoproliferation was noted in the positive control group given HCA at 25%. The study was therefore considered valid.

Parameter:

SI

Value:

0.46

Test group / Remarks:

Group 2: test item 25%

Parameter:

SI

Value:

0.86

Test group / Remarks:

Group 3: test item 50%

Parameter:

SI

Value:

2.16

Test group / Remarks:

Group 4: test item 100%

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: see Remark

Remarks:

DPM per group: Group 1: vehicle: 1150.47 Group 2: test item 25%: 526.98 Group 3: test item 50%: 990.73 Group 4: test item 100%: 2484.29 Group 5: HCA 25%: 7650.27 DPM per node: Group 1: vehicle: 143.81 Group 2: test item 25%: 65.87 Group 3: test item 50%: 123.84 Group 4: test item 100%: 310.54 Group 5: HCA 25%: 956.28

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental conditions of this study, the test item, 1,2-DICHLOROETHANE, (batch No. R1104), did not induce delayed contact hypersensitivity in the murine Local Lymph Node Assay.

Executive summary:

The potential of the test item, 1,2-DICHLOROETHANE, to induce delayed contact hypersensitivity, was evaluated using the murine Local Lymph Node Assay (LLNA). Evaluation of local irritation was also carried out in parallel.

 

Methods

 

A preliminary test was first performed in order to define the concentrations of test item to be used in the main test.

In the main test, twenty female CBA/J mice were allocated to five groups:

·          three treated groups of four animals receiving the test item at the concentration of 25, 50 or 100% in a mixture acetone/olive oil (4/1; v/v) (vehicle),

·          one negative control group of four animals receiving the vehicle,

·          one positive control group of four animals receiving the reference item, a-hexylcinnamaldehyde (HCA), a moderate sensitizer, at the concentration of 25% in the vehicle.

 

During the induction phase, the test item, vehicle or reference item was applied over the ears (25 µL per ear) for 3 consecutive days (days 1, 2 and 3). After 2 days of resting, the proliferation of lymphocytes in the lymph node draining the application site was measured by incorporation of tritiated methyl thymidine (day 6). The obtained values were used to calculate Stimulation Indices (SI).

 

The irritant potential of the test item was assessed in parallel by measurement of ear thickness on days 1, 2, 3 and 6.

 

Results

 

The test item was soluble in the first recommended vehicle, acetone/olive oil (4/1, v/v).A solution was obtained at the maximum tested concentration of 50%.

 

Consequently, the concentrations selected for the preliminary test were 10, 25, 50 and 100%.

 

Since the test item was non-irritant in the preliminary test, the highest concentration retained for the main test was the maximal practicable concentration (100%).

 

Neither mortality nor clinical signs were observed during the study.

 

No cutaneous reactions and no notable increase in ear thickness were observed in the animals of the treated groups.

 

A significant lymphoproliferation was noted in the positive control group given HCA at 25%. The study was therefore considered valid.

No notable lymphoproliferation was noted at any tested concentration.

 

The results are presented in the following table:

 

Treatment	Concentration (%)	Irritation level	Stimulation Index (SI)
Test item	25	non-irritant	0.46
Test item	50	non-irritant	0.86
Test item	100	non-irritant	2.16
HCA	25	-	6.65

 

Conclusion

Under the experimental conditions of this study, the test item, 1,2-DICHLOROETHANE, (batch No. R1104), did not induce delayed contact hypersensitivity in the murine Local Lymph Node Assay.

Reference 3

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The original study is available in Japanese only. The following evaluation is based on an English translation (Harlan Japan) of the report. The study was carried out according to the skin sensitisation test method applying the local lymph node assay, method B.42, suggested by the European Commission with acceptable restrictions.

Qualifier:

according to guideline

Guideline:

EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)

GLP compliance:

no

Type of study:

mouse local lymph node assay (LLNA)

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

20 female mice of CBA/J strain (CBA/JNCrj, SPF) at 9 weeks of age; temperature between 21 and 25 °C, humidity between 40 and 75 %, air exchange rate approximately 15 times/hour, 12 hr light/12 hr darkness

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

10 % solution

No. of animals per dose:

5 animals

Details on study design:

4 groups: 1. 25 uL/ear chloroform; 2. 25 uL/ear acetone:olive oil (4:1); 3. 25 uL/ear 10 % hexyl cinnamic aldehyde in chloroform; 4. 25 uL/ear 10 % hexyl cinnamic aldehyde in acetone:olive oil (4:1)
Application of test solutions to both auricles of the mice for three consecutive days. 3 days later, 3H-methyl thymidine (Amersham Pharmacia Biotech, Inc.) was administered intravenously (250 uL, 2.96 MBq/mL). Five hours later, animals were euthanised. The auricular lymph nodes were removed, in order to compare reactions to HCA with chloroform as vehicle and with acetone:olive oil as vehicle. Cells were isolated from the lymph nodes, cell suspensions prepared and radioactivity was measured with a beta scintillation counter.

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Statistics:

Mean and standard deviation of the data were calculated and the groups were compared using student's t-test

Parameter:

SI

Value:

2.48

Test group / Remarks:

Group 1: Chloroform in AOO (4:1)

Parameter:

SI

Test group / Remarks:

Group 2: AOO (4:1)

Remarks on result:

other: no data

Parameter:

SI

Test group / Remarks:

Group 3: 10% cinnamic aldehyde in chloroform

Remarks on result:

other: no data

Parameter:

SI

Value:

3.49

Test group / Remarks:

Group 4: 10% Hexyl cinnamic aldehyde in AOO (4:1)

In the local lymph node assay, chloroform tended to be higher abundant in the lymph nodes than the acetone/olive oil in the solvent control. The lymphoproliferative activity is used as an index of sensitisation in the LLNA, but since primary irritation also activates lymph cell proliferation through inflammatory cytokine effects, the reactions are said to be difficult to differentiate. Since Montelius et al. (1994) showed activation due to primary irritation in LLNA using methanol/chloroform as the vehicle, it is very likely that the reactions to chloroform seen in the Japanese LLNA study were due to primary irritation rather than sensitisation.

Interpretation of results:

GHS criteria not met

Conclusions:

In contrast to the positive control substance hexyl cinnamic aldehyde, chloroform was characterised to be not sensitising in the local lymph node assay.

Executive summary:

The skin sensitisation potential of chloroform was tested in a local lymph node assay with 20 female CBA/J mice according the the test method B.42 suggested by the European Commission.

Stimulation index determined for chloroform used in the vehicle acetone:olive oil (4:1) at a concentration of 10 % was 2.48, which was below the threshold of 3 indicating sensitising properties. In contrast, the positive control substance hexyl cinnamic aldhehyde used in the vehicle acetone:olive oil (4:1) at a concentration of 10 % had a stimulation index of 3.49 and thus was identified as a skin sensitiser.

In the local lymph node assay, chloroform tended to be higher abundant in the lymph nodes than the acetone/olive oil in the solvent control. The lymphoproliferative activity is used as an index of sensitisation in the LLNA, but since primary irritation also activates lymph cell proliferation through inflammatory cytokine effects, the reactions are said to be difficult to differentiate. Since Montelius et al. (1994) showed activation due to primary irritation in LLNA using methanol/chloroform as the vehicle, it is very likely that the reactions to chloroform seen in the Japanese LLNA study were due to primary irritation rather than sensitisation. In conclusion, chloroform should be considered as not sensitising to the skin.

Reference 4

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The original study is available in Japanese only. The following evaluation is based on an English translation (Harlan Japan) of the report. The study was carried out according to the skin sensitisation test method B.6 suggested by the European Commission with acceptable restrictions.

Qualifier:

according to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

GLP compliance:

no

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

At the time of study completion (2002), the LLNA OECD test method was not adopted.

Species:

guinea pig

Strain:

Hartley

Sex:

female

Details on test animals and environmental conditions:

five weeks old female guinea pigs; temperature between 21 and 25 °C, humidity between 40 and 75 %, air exchange rate 15 times/hour, 12hr light/12 hr darkness

Route:

intradermal

Vehicle:

unchanged (no vehicle)

Concentration / amount:

no data

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Concentration / amount:

no data

No. of animals per dose:

5 animals for sensitisation test with chloroform, 3 animals for controls

Details on study design:

Day 1: intradermal administration of chloroform and Freund's complete adjuvant as primary sensitisation (five test animals)
Day 8: open application of 10 % sodium lauryl sulfate as secondary sensitisation (five test animals)
Day 9: 48 hours application of occlusive patch as patch sensitisation (five test animals)
Day 22: 24 hours application of occlusive patch as challenge (five test animals, three control animals)

Challenge controls:

challenge controls with 24 hours application of occlusive patch on Day 22 with three control animals

Positive control substance(s):

no

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

No data

No. with + reactions:

5

Total no. in group:

5

Clinical observations:

erythema (score 1 or 2, slight to mild) was observed in all animal

Reading:

2nd reading

Hours after challenge:

72

Group:

test chemical

Dose level:

No data

No. with + reactions:

5

Total no. in group:

5

Clinical observations:

erythema (score 1 or 2, slight to mild) was observed in all animal

Reading:

1st reading

Hours after challenge:

48

Group:

negative control

Dose level:

No data

No. with + reactions:

3

Total no. in group:

3

Clinical observations:

erythema (score 1 or 2, slight to mild) was observed in all animal

Group:

positive control

Remarks on result:

not measured/tested

Significant suppression of body weight gain compared to the control group was seen at secondary sensitisation (Day 9) after intradermal chloroform administration (Day 1). Extensive necrosis at the chloroform administration site was observed from the day after administration, and piloerection and decreased spontaneous movement were observed for one week following intradermal administration. In the evaluations at 48 and 72 hours after the start of the challenge, erythema (score 1 or 2, slight to mild) was observed in all eight animals including the three control group animals. This reaction at the challenge site was observed until 8 days after the start of challenge, with a tendency for the erythema to become stronger over time in all 8 animals including the control group, confirming that chloroform is a strong irritant.

Interpretation of results:

GHS criteria not met

Conclusions:

Sensitisation could not be definitely evaluated due to the strong irritation reaction, but since skin reactions were comparable in the chloroform sensitisation group and the control group, chloroform sensitisation was judged to be negative in GPMT.

Executive summary:

The skin sensitisation potential of chloroform was tested in the guinea pig maximisation test according to test method B.6 suggested by the European Commission. Sensitisation was tested with 5 female Hartley guinea pigs in the sensitisation group and 3 female animals in the control group.

Significant suppression of body weight gain compared to the control group was seen at secondary sensitisation (Day 9) after intradermal chloroform administration (Day 1). Extensive necrosis at the chloroform administration site was observed from the day after administration, and piloerection and decreased spontaneous movement were observed for one week following intradermal administration. In the evaluations at 48 and 72 hours after the start of the challenge, erythema (score 1 or 2, slight to mild) was observed in all eight animals including the control group. This reaction at the challenge site was observed until 8 days after the start of challenge, with a tendency for the erythema to become stronger over time in all 8 animals including the control group, confirming that chloroform is a strong irritant.

Sensitisation could not be definitely evaluated due to the strong irritation reaction, but since skin reactions were comparable in the chloroform sensitisation group and the control group, chloroform sensitisation was judged to be negative in GPMT.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

Carbon tetrachloride:

The potential of carbon tetrachloride to induce skin sensitisation was evaluated using the murine Local Lymph Node Assay (LLNA) (Rokh, 2010). Since the test item was non-irritant in the preliminary test, the highest concentration retained for the main test was the maximum concentration. In the main test, the three concentrations used in the treated groups were 25%, 50% or 100%. A dose-related increase in the SI was noted at all the concentrations (25 %: SI = 1.51; 50 %: SI = 2.39; 100%: SI =6.10) and the threshold of 3 was exceeded at the concentration of 100%.

In the absence of local irritation, the positive lymphoproliferative response observed was attributed to delayed contact hypersensitivity. The EC3 value for carbon tetrachloride was equal to 58%. Therefore, on the basis of a weak relative skin sensitization potency, carbon tetrachloride is classified as skin sensitiser. Moreover, carbon tetrachloride is not known to be a skin sensitiser in humans.

Chloroform:

The skin sensitisation test was carried out with female guinea pigs of Std:Hartley strain and female CBA/J mice (Matsuoka et al. 2002). Guinea pigs were used in the maximisation test, whereas mice were used in the local lymph node assay. Strong irritation reaction was observed in all animals used in the maximisation test, which was comparable in test and control animals. From this it was concluded that chloroform was not sensitising to the skin of guinea pigs. In the local lymph node assay, chloroform tended to be higher abundant in the lymph nodes than the acetone/olive oil in the solvent control. The lymphoproliferative activity is used as an index of sensitisation in the LLNA, but since primary irritation also activates lymph cell proliferation through inflammatory cytokine effects, the reactions are said to be difficult to differentiate. Since Montelius et al. (1994) showed activation due to primary irritation in LLNA using methanol/chloroform as the vehicle, it is very likely that the reactions to chloroform seen in the Japanese LLNA study were due to primary irritation rather than sensitisation. In conclusion, chloroform should be considered as not sensitising to the skin.

Dichloroethane:

The potential of DCE to induce delayed contact hypersensitivity, was evaluated in the murine Local Lymph Node Assay (LLNA, OECD 429) (Rokh, 2010). Since DCE was non-irritant in the preliminary test, the highest concentration retained for the main test was the maximal practicable concentration (100%). In the main test, neither mortality nor clinical signs were observed. No cutaneous reactions and no notable increase in ear thickness were observed in the animals of the treated groups. The SI (Stimulation Index) were 0.46, 0.86 and 2.16 for the following DCE concentrations: 25 %, 50 % and 100%. Therefore, ethylene dichloride was not a sensitiser in the LLNA.

CONCLUSION:

The decision logic for classification of mixtures from the ECHA Guidance on the Application of the CLP Criteria was used to determine the skin sensitising potential of the registered substance.

The registered substance has not been tested itself in appropriate in vitro or in vivo tests but some of its constituents are classified as skin sensitisers 1B (carbon tetrachloride) and is present above the CLP generic concentration limit of 1% that triggers classification of the mixture.

Therefore, the registered substance is classified as a skin sensitiser.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Harmonised classification:

The registered substance has no harmonised classification according to the Regulation (EC) No. 1272/2008 (CLP).

Self-classification:

Based on the typical composition, the registered substance is classified as skin sensitiser: Skin Sens. 1, H317 (May cause an allergic skin reaction) according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

No information was available regarding respiratory sensitisation.