Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
abstract

Data source

Reference
Reference Type:
publication
Title:
Range-Finding Toxicity Data, List III
Author:
Smyth H.F., Carpetnter C.P. and Weil C. S.
Year:
1949
Bibliographic source:
J. Ind. Hyg. Toxicol., 31, 60-62

Materials and methods

Principles of method if other than guideline:
Primary skin irritation was recorded in a 10-grade ordinal series and is based upon the severest reaction that developed on the clipped skin of each 5 albino rabbits within 24 hours of the uncovered application of undiluted sample or of solutions in water, propylene glycol, or acetone.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
open
Preparation of test site:
shaved
Vehicle:
other: undiluted sample or solutions in water, propylene glycol or acetone
Controls:
not specified
Amount / concentration applied:
0.01 mL (undiluted)
Duration of treatment / exposure:
24 hour(s)
Observation period:
no data
Number of animals:
5 animals
Details on study design:
SCORING SYSTEM:
- Method of calculation: Primary skin irritation was recorded in a 10-grade ordinal series and is based upon the severest reaction that developed on the clipped skin; Grade 1: indicated no irritation, Grade 2: least visible capillary injection from the undiluted chemical; Grade 3: strong capillary injection; grade 4: slight erythema; Grade 5: strong erythema, edema or slight necrosis; Grade 6: indicated necrosis when undiluted, Grade 10: indicated necrosis from a 0.01% solution;

Results and discussion

In vivo

Results
Remarks on result:
other:
Remarks:
The primary skin irritation was graded as 2.
Irritant / corrosive response data:
The primary skin irritation was graded as 2.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
Based on the Harmonised classificatation Annesx VI of Regulation (EC) No 1272/2008 (CLP Regulation) the substance is classified as skin irritating cat. 2 (H315).