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Diss Factsheets

Administrative data

Description of key information

The substance is not irritating to the skin or eye of rabbits.

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:
Between 15 January 1985 and 5 February 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study conducted using a method similar to an existing guideline but not complying will aspects of currrent guidelines.
Qualifier:
equivalent or similar to guideline
Guideline:
other: U.S. 40 CFR Section 163.81-5 Federal Register August 22., 1978
Deviations:
not specified
Principles of method if other than guideline:
A group of six rabbits was clipped over a wide area of their backs approximately 24 hours prior to application. The skin remained intact. A dose of 0.5 ml of liquid was applied to the test site. Adjactent areas served as the control. A guaze patch was placed over the treated area and was held in place by a non-irritating tape and then covered by a semi-occullllsive dressing. The wrapping and tape were removed after 4 hours follwed by washing of the site with water. The treated areas were examined for signs of erythema and edema using the Draize method within 30-60 minutes of removal and at 24, 48, and 72 hours.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Animals house in stainless steel cages with elevated wire mesh flooring (1/cage), were acclimated 5 days prior to testing and individually identified by an ear tag. Each cage was identified by a cage card. Husbandry conditions were as follows: Temperature 60 to 75 degrees C Relative Humidity 55+/_ 25% Light 12 hours light/dark cycle diet Wayne 15 % Rabbit Ration and tap water ad libitum.
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: adjacent site used as control
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
30-60 minutes and 24, 48, and 72 hours
Number of animals:
6
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4 hours
Score:
0.83
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 Hours
Score:
0.5
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 Hours
Score:
0.17
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
0.17
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4 Hours
Score:
0.83
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 Hours
Score:
0.33
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 Hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 Hours
Score:
0
Max. score:
4
Reversibility:
fully reversible
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study this substance does not require classification under EU Regulation (EC) No. 1272/2008 for skin irritation.
Executive summary:

A dose of 0.5 ml was applied to the intact skin of six rabbits; the adjacent skin was used as a control. After 4 hours exposure the guaze, tape, and semi-occulsive bandage were removed. The skin of each animal was evaluated according to the method of Draize within 30 -60 minutes of removal of the bandages and test material with water and at 24, 48, and 72 hours. The mean 24, 48, and 72 hour erythema and edema scores were 0.84 and 0.11, respectively. Erythema showed some evidence of reversibility but was not fully reversible at 72 hours. Edema was fully reversible by 48 hours. Based on the results of this study this substance does not require classification under EU Regulation (EC) No. 1272/2008 for skin irritation.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not 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:
Between 28 January 1985 and 5 February 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study conducted in a manner similar to an existing guideline but does not meet all of the current guideline requirements.
Qualifier:
equivalent or similar to guideline
Guideline:
other: U.S. 40 CFR Section 163.81-4 Federal Register August 22, 1978 and subsequently modified in accordance with the revised EPA Pesticide Assessment Guidelines of November 1982
Deviations:
not specified
Principles of method if other than guideline:
A group of six animals were used. A 0.1 ml dose was instilled into the conjunctival sac of one eye; the othere eye served as the untreated control. The animals were observed at 1 hour and the 1, 2, 3, 4 and 7 days in accordance with the method of Draize. The eyes were not washed.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Animals house in stainless steel cages with elevated wire mesh flooring (1/cage), were acclimated 5 days prior to testing and individually identified by an ear tag. Each cage was identified by a cage card. Husbandry conditions were as follows: Temperature 60 to 75 degrees C Relative Humidity 55+/_ 25% Light 12 hours light/dark cycle diet Wayne 15 % Rabbit Ration and tap water ad libitum.
Vehicle:
unchanged (no vehicle)
Controls:
other: The other eye served as the untreated control.
Amount / concentration applied:
0.1 ml of the test material
Duration of treatment / exposure:
Single dose without washing through 7 day observation period
Observation period (in vivo):
1 hour and the 1, 2, 3, 4 and 7 days
Number of animals or in vitro replicates:
6
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 day (24 hours)
Score:
0
Reversibility:
other: No irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 2 day ( 48 hours)
Score:
0
Reversibility:
other: No irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 3 day (72 hours)
Score:
0
Reversibility:
other: No irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 4 day
Score:
0
Reversibility:
other: No irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 7 day
Score:
0
Reversibility:
other: No irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 day (24 hours)
Score:
0
Reversibility:
other: No irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 2 day (48 hour)
Score:
0
Reversibility:
other: No irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 3 day (72 hours)
Score:
0
Reversibility:
other: No irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 4 day
Score:
0
Reversibility:
other: No irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 7 day
Score:
0
Reversibility:
other: No irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 day (24 hours)
Score:
1
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 2 day (48 hours)
Score:
0.67
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 3 day(72 hours)
Score:
0.67
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 4 day
Score:
0.33
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 7 day
Score:
0.5
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 day (24 hours)
Score:
1
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 2 day (48 hours)
Score:
1
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 3 day (72 hours)
Score:
0.67
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 4 day
Score:
0.67
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 7 day
Score:
0.5
Reversibility:
not fully reversible within: 7 days
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study this substance does not require classification under EU Regulation (EC) No. 1272/2008 for eye irritation.
Executive summary:

A group of six animals were used. A 0.1 ml dose was instilled into the conjunctival sac of one eye; the other eye served as the untreated control. The animals were observed at 1 hour and the 1, 2, 3, 4 and 7 days in accordance with the method of Draize. The eyes were not washed. The mean 24, 48, and 72 hour mean cornea, iris, conjuctival erythema and chemosis were 0.0, 0.0, 0.78, and 0.89, respectively. Conjunctival erythema and chemosis showed some evidence of reversibility but was not fully reversible by day 7 when the study was terminated. Based on the results of this study this substance does not require classification under EU Regulation (EC) No. 1272/2008 for eye irritation.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin

A dose of 0.5 ml was applied to the intact skin of six rabbits; tha adjacent skin was used as a control. After 4 hours exposure the gauze, tape, and semi-occulsive bandage were removed. The skin of each animal was evaluated according to the method of Draize within 30 -60 minutes of removal of the bandages and test material with water and at 24, 48, and 72 hours. The mean 24, 48, and 72 hour erythema and edema scores were 0.84 and 0.11, respectively. Erythema showed some evidence of reversibility but was not fully reversible at 72 hours. Edema was fully reversible by 48 hours. Based on the results of this study this substance does not require classification under EU Regulation (EC) No. 1272/2008 for skin irritation.

Eye

A group of six animals were used. A 0.1 ml dose was instilled into the conjunctival sac of one eye; the othere eye served as the untreated control. The animals were observed at 1 hour and the 1, 2, 3, 4 and 7 days in accordance with the method of Draize. The eyes were not washed. The mean 24, 48, and 72 hour mean cornea, iris, conjuctival erythema and chemosis were 0.0, 0.0, 0.78, and 0.89, respectively. Conjunctival erythema and chemosis showed some evidence of reversibility but was not fully reversible by day 7 when the study was terminated. Based on the results of this study this substance does not require classification under EU Regulation (EC) No. 1272/2008 for eye irritation.

Justification for classification or non-classification

Under the conditions of the studies, the test material is not irritating to the skin or the eye of rabbits. In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for irritation effects