Registration Dossier

Administrative data

Description of key information

In a range finding study with rabbits the skin irritation was determined at a scaling of 5 out of 10. 
The test substance applied undiluted on abraded skin for 24 hours under occlusion was moderately irritating.
The substance was tested in 4% dilution in petrolatum with human volunteers and did not produce irritation after 48 hour occlusion.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1949
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data from publication containing range finding results
Qualifier:
according to
Guideline:
other: see Principles of method if other than guideline
Principles of method if other than guideline:
Method: other: For details not reported in this publication see previous publication in Am. J. Ophthalmol. 29, 1363-1372 (1946).
GLP compliance:
no
Species:
rabbit
Type of coverage:
open
Vehicle:
other: initially none; acetone for dilution series of corrosive substances
Amount / concentration applied:
undiluted total volume applied : 0.01 ml
Duration of treatment / exposure:
24 hour(s)
Observation period:
24 hours after exposure
Number of animals:
5
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h
Score:
5
Max. score:
10
Reversibility:
no data
Remarks on result:
other: strong erythema, edema, or slight necrosis

Irritation index: 5 (= strong erythema, edema, or slight necrosis)

Interpretation of results:
irritating
Remarks:
Migrated information
Conclusions:
In a range finding studies with rabbits the skin irritation was determined at a scaling of 5 out of 10. The study is used as key study.
Executive summary:

In a range finding studies with rabbits the skin irritation was determined at a scaling of 5 out of 10.

Strong erythema, edema or light necrosis were observed. Based on the results the substance is considered to be irritant to skin. The study is used as key study.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1949
Reliability:
2 (reliable with restrictions)
Qualifier:
according to
Guideline:
other: see Principles of method if other than guideline
Deviations:
not applicable
Principles of method if other than guideline:
Method: other: For details not reported in this publication see previous publications in J. Ind. Hyg. Toxicol. 26, 269-273 (1944) and J. Ind. Hyg. Toxicol. 30, 63-68 (1948).
GLP compliance:
no
Species:
rabbit
Strain:
other: Albino (not specified)
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
24 hour(s)
Number of animals or in vitro replicates:
5
Details on study design:
Comment: not rinsed
Irritation parameter:
overall irritation score
Time point:
other: 24 h
Score:
9
Max. score:
20

Grade 9

Interpretation of results:
irritating
Remarks:
Migrated information
Conclusions:
The eye irritation was rated 9 out of 20 points in a study with albino rabbits. A score of >5 was indicated as severe injury
Executive summary:

A eye irritating study was conducted with albino rabbits. The eye irritation was rated 9 out of 20 points. A score of >5 was indicated as severe injury. Hence under the conditions of this study the substance is considered to be irritating to eyes.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Applying a worst case approach and using the study with the most severe result, the substance is hereby classified as irritant.


Justification for selection of skin irritation / corrosion endpoint:
Data considered to be reliable for assessment

Justification for selection of eye irritation endpoint:
Data considered to be reliable for assessment

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

Based on the available data and taking the worst case approach into account the substance has to be classified as seriously irritant to eyes and irritant to skin.