Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Range-Finding Toxicity Data: List VI
Author:
Smyth H.F.; Carpenter, C.P.; Weil C.S.; Pozzani, U.C.; Striegel, J.A.
Year:
1962
Bibliographic source:
American Industrial Toxicity Data: List VI 23: 95 - 107
Reference Type:
secondary source
Title:
American Industrial Hygiene Association
Year:
1962
Bibliographic source:
http://www.safe.nite.go.jp/english/ghs/11-mhlw-0074e.html Original source: American Industrial Hygiene Association Journal. Vol. 23, Pg. 95, 1962.

Materials and methods

GLP compliance:
no

Test material

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

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
albino rabbits

Test system

Type of coverage:
open
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.01 ml undiluted
Duration of treatment / exposure:
24 h
Observation period:
not indicated
Number of animals:
5

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
2
Max. score:
10
Reversibility:
not specified
Irritant / corrosive response data:
Only slight congestion in blood capillary, rated as Grade 2 (mild irritant) on a scale of 1 to 10, it was classified as "Not classified" in JIS classification (Category 3 in UN GHS classification).

Applicant's summary and conclusion

Interpretation of results:
Category 3 (mild irritant) based on GHS criteria