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Toxicological information

Skin sensitisation

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
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.

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
other: 20% ethanol / 80% saline (intradermal), vaseline PhH VI (epidermal)
Concentration / amount:
5% and 30%
Challenge
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

Results and discussion

Positive control results:
No tests with a positive control group had been performed. The study had been performed in 1981!

In vivo (non-LLNA)

Resultsopen allclose all
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.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.