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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
Refer to section 13 for details on the read-across justification. The study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.
Reason / purpose for cross-reference:
read-across source
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
No information on reliability check. Induction concentration could have been higher: 0.2% caused slight erythema in 1 of the two animals in the range finding test. However, the study is still considered sufficient for the hazard identification.
GLP compliance:
no
Remarks:
GLP was not yet compulsory at date of study
Type of study:
Buehler test
Justification for non-LLNA method:
A LLNA was not conducted with the test substance as a Buehler test was already available allowing assessment of the skin sensitisation potential of the substance. Moreover, the test substance is corrosive hence any additional testing is not required as per Annex VII column 2 of REACH Regulation (1907/2006).
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Redfern Animal Breeders, Jasons Farm, Old Hay, Brenchley, Kent, UK
- Weight at study initiation: Young, withing range 300 – 400 g
- Sex: Male and female
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
For the determination of a non-irritating concentration: 0.1, 0.2, 0.5, 1.0, 5.0, 10 and 20.0 % w/v (0.4 mL was applied over 6 h)
Dermal induction: 1000 µg test substance / ml (0.4 ml, 0.1 % w/v) for 6 h under closed patches
Challenge: 400 µg test substance/ml (0.4 ml, 0.1 % w/v) for 6 h under closed patches on untreated other flank.
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
For the determination of a non-irritating concentration: 0.1, 0.2, 0.5, 1.0, 5.0, 10 and 20.0 % w/v (0.4 ml was applied over 6 h)
Dermal induction: 1000 µg test substance / ml (0.4 ml, 0.1 % w/v) for 6 h under closed patches
Challenge: 400 µg test substance/ml (0.4 ml, 0.1 % w/v) for 6 h under closed patches on untreated other flank.
No. of animals per dose:
Dose range finding: 16 animals (8 groups of 2 animals)
Treatment group: 20 animals (10 male, 10 female)
Controlgroup: 10 animals (5 male, 5 female)
Key result
Reading:
other: Mean scores
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1% w/v in acetone (challenge dose)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: 3/20 showed a grade of 0.5; in control 2/10 showed a grade 0.5
Key result
Reading:
other: Mean scores
Hours after challenge:
48
Group:
test chemical
Dose level:
0.1% w/v in acetone (challenge dose)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: no erythema was observed in any of the animals
Key result
Reading:
other: Incidence
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
other: Incidence
Group:
positive control
Remarks on result:
not measured/tested

Results for dose range finding study:

Skin reactions were scored after 24 h. Results:
20%: severe erythema 2/2;
10%: severe erythema 2/2;
 5%: severe- moderate 2/2;
 1%: severe- moderate 4/4;
0.5%: moderate-slight 2/2;
0.2%: slight erythema 1/2;
0.1%: No erythema 2/2.

Results for main study:

First grading: 0/20 (3/20 showed a grade of 0.5; in control 2/10 showed a grade 0.5). Second grading: 0/20 (no erythema was observed in any of the animals)

The test substance tested has a narrower chain length distribution compared to full coco. The results from this substance however are fully valid for evaluation of TMAC as:

- The tested substance constitutes already for 70% TMAC, without some additional shorter and longer chain lengths present..

Principally, aspects of sensitisation are related to possible reactivity and protein binding, which are properties that are independent to chain length.

Interpretation of results:
other: CLP criteria not met
Conclusions:
Under the conditions of the Buehler test, the test substance is considered to be non-sensitizing.
Executive summary:

A study was conducted to determine the skin sensitising potential of the read across substance, C12 -14 TMAC, according to a method equivalent to OECD Guideline 406 (Buehler test protocol). A pre-test was conducted to determine the non-irritating concentrations to be used in the main study. For the main study the topical induction was carried out at 0.1% w/v in aqueous ethanol for 6 h, repeated after 7 and 14 d. Challenge was done two weeks after the last induction (Day 28). The control and test animals received 0.1% w/v test substance in acetone for 6 h on previously untreated site under closed patches. After 18 h the sites were treated with depilatory cream, rinsed and dried. After 3 h, challenge sites were evaluated for erythema on a scale of 0 -3. Evaluation was repeated 24 h later. Results of the first grading were: 0/20 (3/20 showed a grade of 0.5; in control 2/10 showed a grade 0.5). Second grading: 0/20 (no erythema was observed in any of the animals). Under the study conditions, the test substance was considered to be non-sensitising to skin(Jones, 1978).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

A study was conducted to determine the skin sensitising potential of the read across substance, C12 -14 TMAC, according to a method equivalent to OECD Guideline 406 (Buehler test protocol). A pre-test was conducted to determine the non-irritating concentrations to be used in the main study. For the main study the topical induction was carried out at 0.1% w/v in aqueous ethanol for 6 h, repeated after 7 and 14 d. Challenge was done two weeks after the last induction (Day 28). The control and test animals received 0.1% w/v test substance in acetone for 6 h on previously untreated site under closed patches. After 18 h the sites were treated with depilatory cream, rinsed and dried. After 3 h, challenge sites were evaluated for erythema on a scale of 0 -3. Evaluation was repeated 24 h later. Results of the first grading were: 0/20 (3/20 showed a grade of 0.5; in control 2/10 showed a grade 0.5). Second grading: 0/20 (no erythema was observed in any of the animals). Under the study conditions, the test substance was considered to be non-sensitising to skin (Jones, 1978).

Justification for classification or non-classification

Based on the results of the read acoss study, the test substance, Quaternary ammonium compounds, C12-14 alkyltrimethyl, Me sulfates, does not warrant classification for skin sensitisation according to EU CLP (1272/2008/EC) criteria.