Registration Dossier

Administrative data

Description of key information

Based on the results of the read across study, the test substance is not considered to be sensitising to skin.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Reason / purpose:
data waiving: supporting information
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
June 1, 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
Refer to the Quaternary ammonium salts (QAS) category or section 13 of IUCLID for details on the category justification.
Qualifier:
equivalent or similar to
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:
1st reading
Hours after challenge:
24
Group:
test group
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:
2nd reading
Hours after challenge:
48
Group:
test group
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
Remarks:
(acetone)
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
Remarks:
not classified
Conclusions:
Based on the results of the read across Buehler test, the test substance is considered to be non-sensitizing.
Executive summary:

A study was conducted to determine the sensitising potential of the read across substance, C12 -14 TMAC, according to a method equivalent to the Buehler test protocol (OECD Guideline 406). A pre-test was conducted to determine non-irritating concentrations to be used in the main study. For the main study the induction was carried out at: topical 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 treatment (Day 28): control and test animals received 0.1% w/v 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 conditions of the Buehler test, the read across substance was not sensitizing (Jones, 1978). Based on the results of the read across study, a similar non-sensitising potential can be expected for the test substance.

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

A study was conducted to determine the sensitising potential of the read across substance, C12 -14 TMAC, according to a method equivalent to the Buehler test protocol (OECD Guideline 406). A pre-test was conducted to determine non-irritating concentrations to be used in the main study. For the main study the induction was carried out at: topical 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 treatment (Day 28): control and test animals received 0.1% w/v 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); test substance was considered to be non-sensitising (Jones, 1978). Based on the results of the read across study, the test substance is also considered to be non-sensitising to skin.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the results of the read across study, the test substance does not warrant a classification for skin sensitisation according to EU CLP criteria (Regulation EC 1272/2008).