Registration Dossier

Administrative data

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:
1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions: No positive control (not required by 1981 version of Test Guideline) was used, but some reaction and inflamation of the skin due to irritation was observed, showing reactivity of the test system.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
(1981)
GLP compliance:
no
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Vehicle:
corn oil
Concentration / amount:
5% intracutaneous induction, 50% epidermal induction and 20% epidermal challenge
Vehicle:
corn oil
Concentration / amount:
5% intracutaneous induction, 50% epidermal induction and 20% epidermal challenge
No. of animals per dose:
20
Details on study design:
1st application: Induction 5 % intracutaneous
2nd application: Induction 50 % occlusive epicutaneous
3rd application: Challenge 20 % occlusive epicutaneous
Reading:
1st reading
Hours after challenge:
24
Group:
other: treated group and control group
Dose level:
5% intracutaneous induction, 50% epidermal induction and 20% epidermal challenge
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
only irritation
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: other: treated group and control group. Dose level: 5% intracutaneous induction, 50% epidermal induction and 20% epidermal challenge. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: only irritation.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: treated group and control group
Dose level:
5% intracutaneous induction, 50% epidermal induction and 20% epidermal challenge
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
only irritation
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: treated group and control group. Dose level: 5% intracutaneous induction, 50% epidermal induction and 20% epidermal challenge. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: only irritation.

RESULTS OF TEST
- Sensitization reaction: 
  0/20 animals positive at 24 hours and at 48 hours = no sensitization
  no animals positive in control group
- Clinical signs: only irritation
  1st induction, FCA application sites: severe erythema, edema, and  necroses
  1st induction, vehicle + FCA application sites: severe erythema and  edema
  1st induction, vehicle application sites: slight erythema and edema
  1st induction, vehicle + test substance application sites: slight  erythema and edema
  2nd induction, test group: severe inflammation of all FCA injection  sites with discharge of pus; after 1 hour bleeding wounds from  scratching; crust formation within 24 hours
  2nd induction, control group: no findings reported
- Other: Mean body weight gain 136.3 g in test group, 126.5 g in control  group = expected range

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Following OECD 406 the test substance diluted at 5%, 50% and 20% in corn oil was successively administerd to 20 animals. No sensitizing effects were observed after 24 and 48 hours. The substance is considered non sensitizing.
Executive summary:

Following OECD 406 the test substance diluted at 5%, 50% and 20% in corn oil was successively administerd to 20 animals. No sensitizing effects were observed after 24 and 48 hours. Under the conditions of this study the substance is considered non sensitizing.

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

According to the outcome of the study no sensitizing effects were observed after 24 and 48 hours. The substance is considered non sensitizing based on the results of the study.


Migrated from Short description of key information:
An OECD 406 test was selected as key study. The substance diluted 20% in corn oil was administerd to 20 animals. No sensitizing effects were observed after 24 and 48 hours. The substance is considered non sensitizing.

Justification for classification or non-classification

Based on the outcome of the study no classification is needed regargding to this endpoint.