Registration Dossier

Administrative data

Description of key information

Skin sensitisation (similar OECD 406, guinea pigs): not sensitising

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
09 Feb - 19 Mar 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
lack of test material and study details, no reliability check
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data were included to avoid unnecessary testing.
Species:
guinea pig
Strain:
other: Pirbright white
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 10 weeks
- Weight at study initiation: 270-400 g
- Housing: animals were housed individually in Macrolon III cages.
- Diet: standard guinea-pig pellets - NAFAG No. 830 (Gossau SG), ad libitum and supplemented with fresh carrots.
- Water: ad libitum
- Acclimation period: 10 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 50 ± 10
- Photoperiod (hrs dark / hrs light): 14/14
Route:
intradermal and epicutaneous
Vehicle:
other: 20% ethanol / 80% saline (intradermal), vaseline PhH VI (epidermal)
Concentration / amount:
5% and 30%
Route:
epicutaneous, occlusive
Concentration / amount:
3%
No. of animals per dose:
20
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture adjuvant (Bacto Adjuvant complete Freund, Difco) and saline
Injection 2: test substance in saline
Injection 3: a mixture of the test substance with the adjuvant saline mixture

Epicutaneous: test substance in vaseline
- Control group: no information
- Site: neck region
- Frequency of applications: every 7 days
- Duration: Days 0-8
- Concentrations: intradermal 5%, epicutaneous 30%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 20
- Exposure period: 24 h
- Test groups: test substance
- Control group: vehicle only
- Site: flank
- Concentrations: 3%
- Evaluation (hr after challenge): 48 h

OTHER: The application sites were chemically depilated 3 h before examination.
Positive control substance(s):
no
Positive control results:
No tests with a positive control group had been performed. The study had been performed in 1981!
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
induction: 5 and 30%; challenge: 3%
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
induction: 5 and 30%; challenge: 3%
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
3 animals with very slight erythema and 2 animals with well defined erythema
Remarks on result:
other: see Remark
Remarks:
Clinical observations: 3 animals with very slight erythema and 2 animals with well defined erythema.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The skin sensitising properties of N-methyl-N-(C18-(unsaturated)alkanoyl)glycine were tested in a guinea pig maximisation test similar to OECD Guideline 406 (Ciba Geigy, 1981c).

In the study, Pirbright white guinea pigs (20/group) were induced with a single intradermal injection of the test substance at 5% (in 20% ethanol, 80% saline) using the adjuvant complete Freund and an epicutaneous application of the test substance at 30% (Vaseline PhH VI) on the injection site. The negative control group was included in the study but no information about treatment was given. Epicutaneous challenge exposure was conducted 20 days after the first induction for 24 h under occlusive conditions. 3% of the test substance was applied on the flank. Evaluation of skin reactions was carried out 24 h after challenge. No positive control substance was included in the study.

No skin reactions were observed in any animal in the negative control group. In the treatment group, three animals with very slight erythema and two animals with well defined erythema were observed (corresponding to 25% positive results).

Thus, the available data on skin sensitisation do not provide evidence for sensitising properties of N-methyl-N-(C18-(unsaturated)alkanoyl)glycine under the conditions of the study.


Justification for selection of skin sensitisation endpoint:
Only one study available.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Justification for selection of respiratory sensitisation endpoint:
Study not required according to Annex VII-X of Regulation (EC) No 1907/2006.

Justification for classification or non-classification

The available data on skin sensitisation do not meet the criteria for classification according to Regulation (EC) No 1272/2008 and are therefore conclusive but not sufficient for classification.