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Diss Factsheets

Administrative data

Description of key information

The test substance did not show any skin senstising properties

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:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
Skin Sensitisation (Ear/Flank Method, Stevens (1967))
Seven male guinea pigs were used for this test. On days 0, 1 and 2 of the test, 0.1 ml of the test agent was applied to the outer surface of the ears of four animals only. On day 6, 0.2 ml of the challenge solutions in dimethyl formamide (DMF) were applied topically to the clipped flanks of all seven animals. On day 7 the erythema which had developed at each site was rated on a 5-point scale. In the pre-treated animals, only erythema in excess of that present in the controls was considered to denote sensitisation; that present in the controls, denoted simple primary irritation.
GLP compliance:
no
Type of study:
other: Stevens ear/flank test
Justification for non-LLNA method:
The test method was not available at the time of testing
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Zeneca Alderly Park
- Weight at study initiation: 300 to 500 g
Route:
epicutaneous, open
Vehicle:
other: DMF
Concentration / amount:
10% 0.1 mL for each ear
Day(s)/duration:
3 consecutive days
No.:
#1
Route:
epicutaneous, open
Vehicle:
other: DMF
Concentration / amount:
0.2 mL 0.1% and 10%
Day(s)/duration:
1
No. of animals per dose:
3 control
4 treated
Details on study design:
Seven male guinea pigs were used for this test. On days 0, 1 and 2 of the test, 0.1 ml of the test agent was applied to the outer surface of the ears of four animals only. On day 6, 0.2 ml of the challenge solutions in dimethyl formamide (DMF) were applied topically to the clipped flanks of all seven animals. On day 7 the erythema which had developed at each site was rated on a 5-point scale. In the pre-treated animals, only erythema in excess of that present in the controls was considered to denote sensitisation; that present in the controls, denoted simple primary irritation.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1%
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
3

No evidence of erythema was produced by any of the challenge applications.

Interpretation of results:
other: non-sensitiser
Conclusions:
The test substance did not show any skin senstising properties
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

No signs of skin sensitisation occurred. Therefore, no classification applies.