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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:
experimental study
Adequacy of study:
key study
Study period:
20 April 1999 - 4 June 1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was performed according to OECD guideline and GLP. The report is however very concise and does not contain full details on methods and results.
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
see below
Principles of method if other than guideline:
- only 3 control animals and 5 test group animals were used.
- the study followed OECD guideline but it is not mentioned if the challenge was done under occlusion or for how long.
- the report is however very concise and does not contain full details on methods and results.
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
In-vivo data from a non-LLNA method has already existed.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Nossan S.r.l., Italy
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: No data
Route:
intradermal and epicutaneous
Vehicle:
petrolatum
Concentration / amount:
Induction (injection): 0.5% in water and 0.5% in FCA emulsion
Induction (topical): 60% in petrolatum
Challenge: 60% in petrolatum
Route:
other: the study followed OECD guideline but it is not mentioned if the challenge was done under occlusion or for how long.
Vehicle:
petrolatum
Concentration / amount:
Induction (injection): 0.5% in water and 0.5% in FCA emulsion
Induction (topical): 60% in petrolatum
Challenge: 60% in petrolatum
No. of animals per dose:
control group: 3
test group: 5
Details on study design:
Animals were allocated to treatment to give a test group of 5 animals and a control group of 3 animals. In an attempt to induce sensitisation, test animals were intradermally injected with an emulsion of Freund's complete adjuvant and the test substance in both the selected vehicle and an emulsion of Freund's complete adjuvant. One week later this was boosted by topical application of the test substance over the injection sites which had been pre-treated with sodium lauryl sulphate to promote an irritant reaction.
Control group animals were treated in the same manner but the selected vehicle was used in place of the test substance. Two weeks after the second induction stage, all animals were challenged by topical application of both the vehicle and the test substance. The concentrations of the test substance used were determined by preliminary screening tests.
No further data.
Positive control substance(s):
no
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
60%
No. with + reactions:
0
Total no. in group:
3
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 60%. No with. + reactions: 0.0. Total no. in groups: 3.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
60%
No. with + reactions:
0
Total no. in group:
3
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 60%. No with. + reactions: 0.0. Total no. in groups: 3.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
60%
No. with + reactions:
5
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 60%. No with. + reactions: 5.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
60%
No. with + reactions:
5
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 60%. No with. + reactions: 5.0. Total no. in groups: 5.0.
Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The results indicate that the test substance may elicit a sensitisation response in the guinea pig, there being a 100% incidence of response at challenge following a period of induction exposure to the substance
Executive summary:

The study was performed according to OECD guideline and GLP. The results indicate that the test substance may elicit a sensitisation response in the guinea pig, there being a 100% incidence of response at challenge following a period of induction exposure to the substance.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

The results indicate that the test substance may elicit a sensitisation response in the guinea pig, there being a 100% incidence of response at challenge following a period of induction exposure to the substance (5/5) and no response in the control animals (0/3). Although the number of animals in the study is limited the result is 100% positive and the conclusion is that the substance is a skin sensitizer.


Migrated from Short description of key information:
The results indicate that the test substance may elicit a sensitisation response in the guinea pig.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available results the substance is classified as a cat.1 skin sensitizer.