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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 1, 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978

Materials and methods

Test guideline
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).

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N,N-trimethyl-C12-14 (even numbered)-alkyl-1-aminium chloride
Molecular formula:
C15H34Cl1N1 (representative molecular formula of C12 chain)
IUPAC Name:
N,N,N-trimethyl-C12-14 (even numbered)-alkyl-1-aminium chloride

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Induction
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.
Challenge
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)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
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:
2nd reading
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
Dose level:
no test chemical
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

Any other information on results incl. tables

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.

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Remarks:
not classified
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 sensitising potential of the test 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 test substance was not sensitizing (Jones, 1978).