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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19th July 1982 - 6th August 1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
The study was conducted in accordance with GLP and similar/equivalent OECD 404 guideline.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Rabbits were housed individually in cages sized in accordance with the Guide for the Care and use of Laboratory Animals of the Institute of Laboratory Animals of the Institue of Laboratory resources, Nationals Research Council. Waste Material was removed daily. Cages and feeders were sanitized every two weeks.Light cycle: 12hours light , 12 hours dark , Temperature/Humidity - every attempt was made to maintain a temperature of 20oC +/- 3 deg.Centigrade.and a humidity of 30-70%. Food and water was provided ad libitum and checked daily, added or replaced as required.
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Remarks:
Each rabbit was tested at two abraded and two intact sites.
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
O.5ml of the neat test material
Duration of treatment / exposure:
24 hours
Observation period:
14 days
Number of animals:
6
Details on study design:
The skin of each 6 aldult albino rabbits were clipped free of furThe skin was abraded using a 21 guage butted needle. The abrassion penetrated the stratum corneum but not the derma. Following the application of the test material, one -inch square guaze patches were applied to each of the four sites the trunk of the animal was then wrapped with a rubber dam and an Ace bandage to retard evapouration. The test material was kept in contact with the skin for 24 hours. At the end of the 24hrs exposure period, the wrapping were removed and skin wiped to remove remaining test material.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24/72 h
Score:
0.85
Max. score:
1
Reversibility:
fully reversible within:
Remarks:
14 days observation period
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/72 h
Score:
0.925
Max. score:
2
Reversibility:
fully reversible within:
Remarks:
14days observation period
Irritant / corrosive response data:
Individual animal scores are given below for 24 and 72 hours observations for the intact skin:

24hrs
Erythema Edema
Animal 1 1 0
Animal 2 1 1
Animal 3 1 1
Animal 4 1 0.5
Animal 5 1 1
Animal 6 1 1

72 hrs
Erythema Edema
Animal 1 0 1
Animal 2 1 1
Animal 3 1 2
Animal 4 0 1
Animal 5 1 1
Animal 6 1 1.5

14 days
Erythema Edema
Animal 1 0 0
Animal 2 0 0
Animal 3 0 0.5
Animal 4 0 0
Animal 5 0 0
Animal 6 0 0
Interpretation of results:
GHS criteria not met
Conclusions:
The results from the study considers the test material to be Not irritating to skin. Therefore, in accordance with the criteria set in the CLP guidance document, the substance should not be classified for skin irritation.
Executive summary:

The test substance was assessed for dermal irritation effects on rabbit skin. Substance was applied intact and abraded skin site. Slight to very slight erythema and edema was observed within 24hours. At 72 hours, well defined edema was observed. Slight Erythema was observed on day 4 through day 13 of the study and slight edema was observed on day 4 through day 14 after treatment and the study was terminated on day 14. Therefore, based upon the observations made in the acute dermal irritation test in rabbits, the test substance was determined to be not irritating to the skin under CLP classification criteria.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21st July 1982-28th July 1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Six rabbits were selected based upon body weight and kept for 5 days acclimation period. Cages were marked with an animal group number and dose level. All Rabbits were ear tagged. Light cycle of 12hours light , 12hours dark. Every attempt was made to maintain a temperature of 20oC +/-3oC and a humidity of 30-70%. Rabbits were housed individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the institute of Laboratory resources, National Research Council. Waste material was removed daily and cages and feeders were sanitized every two weeks. Food and water was provided ad libitum and checked daily, added or replaced as required.
Vehicle:
unchanged (no vehicle)
Controls:
other: Only one eye was treated with Test material the other eye served as control.
Amount / concentration applied:
0.1ml
Duration of treatment / exposure:
Test substance was placed in the right eye of each animal by gently pulling the lower lid away from the eyeball to form a cup. The upper and lower lids were then held together for one seconf to prevent loss of material
Observation period (in vivo):
7 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within:
Remarks:
7days
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible within:
Remarks:
7days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.623
Reversibility:
fully reversible within:
Remarks:
7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
2.12
Reversibility:
fully reversible within:
Remarks:
7days
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Based upon the observations made in the Acute Eye Irritation Test in Rabbits, the test substances is determined to be an eye irritant. Therefore, in accordance with the criteria set forth by the CLP cguidances, the test substance will be classified as Eye irritant , Cat. 2, H319.
Executive summary:

Six animals (3 males and 3 females) were exposed to 0.1ml of the test substance. Positive occular responses were observed at 1, 24,48,72hours after treatment. No positive responses were observed on day 7, at which time the study was terminated. Seventeen positive responses were redoed during the course of the study. Immediately following the 48 hour reading a rabbit died. However, necropsy revealed the death was non- compound related. Based upon the observations made in the Acute Eye Irritation Test in rabbits, the test substances is determined to be an eye irritant. Therefore, in accordance with the criteria set forth by the CLP cguidances, the test substance will be classified as Eye irritant , Cat. 2, H319.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Justification for classification or non-classification

Skin Irritation: - The results from the study considers the test material to be Not irritating to skin. Therefore, in accordance with the criteria set in the CLP guidance document, the substance should  not be classified for skin irritation.

Eye irritation:- Based upon the observations made in the Acute Eye Irritation Test in Rabbits, the test substances is determined to be an eye irritant. Therefore, in accordance with the criteria set forth by the CLP cguidances, the test substance will be classified as Eye irritant , Cat. 2, H319.