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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin irritation

The test substance was considered to be moderately irritating to the skin of rabbits.

Eye irritation

Under the conditions of the study, the test substance was considered to be moderately irritating to the eye of rabbits.  The results indicate no means scores above 1 after 24 hours and fully reversed by 72 hours.

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:
August 1983 to 19 September 1983
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
other: New England White
Details on test animals or test system and environmental conditions:
SOURCE ANIMAL
- Source: Externally sourced
- Sex: Male
- Weight at study initiation: Ranges from 2.38 to 2.96 Kg
- Housing: All housing and care conformed to the standards established in "Guide for the Care and Use of Laboratory Animals" DHEW Publication No. (NIH) 78-23. Animals were individually housed in wire mesh bottom cages in an environment controlled room.
- Diet: The rabbits were provided NIH Animal Feed A (certified) ad libitum
- Water: ad libitum
- Acclimation period: A minimum of 5 days
Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
A volume of 0.5 ml of the test article was applied to each of 2 sites per rabbit.
Duration of treatment / exposure:
4 hours
Observation period:
30 minutes, 24, 48 and 72 hours
Number of animals:
6 animals
Details on study design:
TEST SITE
- Type of wrap if used: Following application, each test site was occluded with a one-inch square gauze patch and Blenderm® tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gently wiped with clean gauze.

OBSERVATION TIME POINTS
- 30 minutes after test material removal and the exposure sites were again examined and scored 24, 48 and 72 hours after unwrapping. Any extraordinary findings, dermal or toxicological, were noted. The animals were also observed and scored on days 4, 7, 10 and 14.

SCORING SYSTEM:
- Method of calculation:the exposure sites were examined and scored separately for both erythema and edema on a graded scale of 0 to 4 in accordance with the Driaze scale.
Irritation parameter:
other: Draize scale
Remarks:
erythema/eschar and oedema
Basis:
mean
Time point:
24/48/72 h
Score:
3.11
Reversibility:
not specified
Remarks on result:
probability of mild irritation

Patches were removed approximately 4 hours after application and excess test substance was removed. At 0.5, 24, 48 and 72 hours after patches removed, the exposure sites were examined and scored separately for both erythema/eschar and oedema on a graded scale of 0 to 4 in accordance with the Skin Reaction Code. The animals were also observed and scored on days 4, 7, 10 and 14. Eschar formation was noted at the test site in 3/6 animals on days 3 and 4. On days 7 and 10, 2/6 animals exhibited eschar formation and 4/6 animals exhibited cracked, flaking skin on the surface layer of the test site. Day 14 observations revealed eschar formation in 1/6 animal and 5/6 animals exhibited cracked, flaking skin on the surface layer of the test site. The individual primary irritation score was that total scores of erythema/eschar and oedema at 0.5, 24, 48 and 72 hours after patches removed divided by 6. The mean primary irritation score of six rabbits was 3.11. The test substance was considered to be moderately irritating to the skin of rabbits.

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The test substance was considered to be moderately irritating to the skin of rabbits.
Executive summary:

To determine the potential of the test material to cause irritation to the skin a study was conducted in accordance to OECD guidelines under GLP conditions. The study has been given a Klimisch score of 1 and is considered to be a key study. Six male New England White rabbits were treated with 0.5 mL test material/site, 2 sites/rabbit; occlusive coverage for 4 hour treatment. Patches were removed approximately 4 hours after application and excess test substance was removed. At 0.5, 24, 48 and 72 hours after patches removed, the exposure sites were examined and scored separately for both erythema/eschar and oedema on a graded scale of 0 to 4 in accordance with the Skin Reaction Code. The animals were also observed and scored on days 4, 7, 10 and 14. Eschar formation was noted at the test site in 3/6 animals on days 3 and 4. On days 7 and 10, 2/6 animals exhibited eschar formation and 4/6 animals exhibited cracked, flaking skin on the surface layer of the test site. Day 14 observations revealed eschar formation in 1/6 animal and 5/6 animals exhibited cracked, flaking skin on the surface layer of the test site. The individual primary irritation score was that total scores of erythema/eschar and oedema at 0.5, 24, 48 and 72 hours after patches removed divided by 6. The mean primary irritation score of six rabbits was 3.11. Under the conditions of this study, the test substance was considered to be moderately irritating to the skin of rabbits.

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:
August 1983
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Specific details on test material used for the study:
Sponsor Test Article ID : OD-826, Lot #DU71/2
Species:
rabbit
Strain:
other: New England White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Externally sourced
- Sex: Female
- Weight at study initiation: Ranged from 2.36 to 2.78 Kg
- Housing: All housing and care conformed to the standards established in "Guide for the Care and Use of Laboratory Animals" DHEW Publication No. (NIH) 78-23. The rabbits were individually housed in wire mesh bottom cages in an environment controlled room.
- Diet: NIH Animal Feed A (certified), ad libitum
- Water: as libitum
- Acclimation period: A minimum of 5 days
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.1 ml of the test substance
Duration of treatment / exposure:
1 dose / 14 days exposure
Observation period (in vivo):
1, 24, 48 and 72 hours. Readings were made every 3 day thereafter, if injury persisted, for at least 13 days after treatment.
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not specified

SCORING SYSTEM:
- Draize Scale

TOOL USED TO ASSESS SCORE:
- Sodium fluorescein
Irritation parameter:
other: Draize Scale
Remarks:
Mean Eye Irritation Scores
Basis:
mean
Time point:
other: 1 hour
Score:
6
Reversibility:
not specified
Irritation parameter:
other: Draize Scale
Remarks:
Mean Eye Irritation Scores
Basis:
mean
Time point:
24 h
Score:
0.7
Reversibility:
not specified
Irritation parameter:
other: Draize Scale
Remarks:
Mean Eye Irritation Scores
Basis:
mean
Time point:
48 h
Score:
0.3
Reversibility:
not specified
Irritation parameter:
other: Draize Scale
Remarks:
Mean Eye Irritation Scores
Basis:
mean
Time point:
72 h
Score:
0
Reversibility:
not specified

The treated eyes were examined with the aid of sodium fluorescein and the grade of ocular reaction was recorded for all animals at l, 24, 48 and 72 hours using the Draize Scale for Scoring Ocular Lesions. Readings were made every 3 day thereafter, if injury persisted, for at least 13 days after treatment or until all signs of reversible toxicity subsided. The mean eye irritation scores were 6.0, 0.7, 0.3 and 0 at l, 24, 48 and 72 hours, respectively. The test substance was considered to be moderately irritating to the eye of rabbits.

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the study, the test substance was considered to be moderately irritating to the eye of rabbits. The results indicate no means scores above 1 after 24 hours and fully reversed by 72 hours.
Executive summary:

To determine the potential of the test material to cause irritation to the eye a study was conducted in accordance to OECD guidelines under GLP conditions. The study has been given a Klimisch score of 1 and is considered to be a key study. Six female New England White rabbits were treated with 0.1 mL test material in one eye and the other eye remained untreated and this was used as a control. The treated eyes were examined with the aid of sodium fluorescein and the grade of ocular reaction was recorded for all animals at 1, 24, 48 and 72 hours using the Draize Scale for Scoring Ocular Lesions. Readings were made every 3 day thereafter, if injury persisted, for at least 13 days after treatment or until all signs of reversible toxicity subsided. The mean eye irritation scores were 6.0, 0.7, 0.3 and 0 at 1, 24, 48 and 72 hours, respectively. The test substance was considered to be moderately irritating to the eye of rabbits.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based upon a skin irritation study, the test substance is classified as a skin irritant.