Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: acceptable publication which meets basic scientic principles; basic data on expermimental design are given.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Range-Finding Toxicity Data: List VII
Author:
Smyth, HF; Carpenter, CP; Weil, CS; Pozzani UC; Striegel JA; Nycum, JS
Year:
1969
Bibliographic source:
Amer. Ind. Hyg. Assoc. J. 30 (1969), 470
Report Date:
1969
Reference Type:
publication
Title:
Range-Finding Toxicity Data: List VI
Author:
Smyth, HF; Carpenter, CP; Weil, CS; Pozzani UC; Striegel JA
Year:
1962
Bibliographic source:
Amer. Ind. Hyg. Assoc. J. 23 (1962), 95
Report Date:
1962

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
primary skin irritation test. 0,01 ml of undiluted sample or solutions in water, acetone or propylene glycol are applied to clipped skin of 5 albino rabbits. After 24h the reaction is graded on a scale from 1 to 10.
GLP compliance:
no
Remarks:
pre-GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no further details given

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
no data

Test system

Type of coverage:
open
Preparation of test site:
other: clipped
Vehicle:
other: either acetone or propylene glycol
Controls:
not specified
Amount / concentration applied:
0,01 ml
Duration of treatment / exposure:
24h
Observation period:
24h
Number of animals:
5
Details on study design:
TEST SITE
- Area of exposure: rabbit belly
- % coverage: no data
- Type of wrap if used: application site uncovered

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data

SCORING SYSTEM: scoring in grading system from 1 to 10. 1 indicates no irritiation, 2 the least visible capillary injection from the undilted chemical. Grade 6 indicates necrosis, when undiluted and grade10 indicates necrosis from a 0,01% solution.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
other: no data
Time point:
other: 24 h
Score:
1
Max. score:
10
Reversibility:
other: not applicable
Remarks on result:
other: own grading system, 1= no effect

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

the primary skin irritation of a 0,01% solution of the test substance on the clipped belly of albino rabbits on a 24h exposure period was tested on each of 5 rabbits. The result score of 1 out of a scale of 10 corresponds to no irritation having been observed under test conditions.