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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The test material is not irritating to the skin of rabbits (equivalent or similar to 16 CFR 1500.41 of the Federal Hazardous Substances Act Regulations)

 

Eye irritation in vivo

The test material is not irritating to the eyes of rabbits (equivalent or similar to 16 CFR 1500.41 of the Federal Hazardous Substances Act Regulations)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Remarks:
In vivo testing previously conducted before in vitro rules came into force
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980-12-9 to 1980-12-12
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
24 hour exposure and termination at 72 hours without evidence of reversibility
Justification for type of information:
Test conducted prior to the introduction of in vitro methods.
Qualifier:
equivalent or similar to guideline
Guideline:
other: Section 1500.41- Federal Hazardous Substances Act Regulations - 16 CFR
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
24 hour exposure to the test material
Principles of method if other than guideline:
Six albino rabbits were clipped and then one side of the back was abraded to penetrate the stratum corneum with the other side kept intact. A 0.5 mL portion of the test material was applied to an abraded and an intact skin site of the same rabbit. A gauze patch was placed over each application site and an impervious material was wrapped around the trunk of the animal to hold the patches. The wrapping was removed after 24h. Treated areas were examined at 24h after treatment and scoring using the Draize method was done at 72h after treatment.
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
No data
Type of coverage:
occlusive
Preparation of test site:
other: abraded and intact
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
24 hour
Observation period:
72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: back
- % coverage: not specified
- Type of wrap if used: gauze patch covered by impervious material.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #1
Time point:
other: mean 24/72 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #1
Time point:
other: mean 24/72 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #2
Time point:
other: Mean 24/72 hours
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #2
Time point:
other: mean 24/72 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #3
Time point:
other: mean 24/72 h
Score:
0.5
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #3
Time point:
other: mean 24/72 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #4
Time point:
other: mean 24/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #4
Time point:
other: mean 24/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #5
Time point:
other: mean 24/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #5
Time point:
other: mean 24/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #6
Time point:
other: mean 24/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #6
Time point:
other: mean 24/72 h
Score:
0.5
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #1
Time point:
other: mean 24/72 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #1
Time point:
other: mean 24/72 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #2
Time point:
other: mean 24/72 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #2
Time point:
other: mean 24/72 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #3
Time point:
other: mean 24/72 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #3
Time point:
other: mean 24/72 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #4
Time point:
other: mean 24/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #4
Time point:
other: mean 24/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal #5
Time point:
other: mean 24/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #5
Time point:
other: mean 24/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #6
Time point:
other: mean 24/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #6
Time point:
other: mean 24/72 h
Score:
0.5
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
- Very slight erythema was observed at the intact skin in two and three animals at 24 and 72 hours, respectively. Whereas in abraded skin, very slight erythema was observed in three and four animals at 24 and 72 hours, respectively. At 24 and 72 hours, very slight edema was observed in intact skin of three animals. At 24 and 72 hours, very slight edema was observed in abraded skin of two and three animals, respectively; whereas slight edema was observed in abraded skin of one animal at 24 and 72 hours.
- There was no evidence of reversibility over the limited timeframe of the study.
Other effects:
No data

Table 7.3.1/1: Primary skin irritation

Erythema and Eschar Formation

Reading (hrs)

Rabbit number

Average

1

2

3

4

5

6

Intact Skin

24

1

1

0

0

0

0

0.33

Intact Skin

72

1

1

1

0

0

0

0.50

Abraded Skin

24

1

1

1

0

0

0

0.50

Abraded Skin

72

1

1

1

0

0

1

0.67

Subtotal

2.00

Edema Formation

Intact Skin

24

1

1

1

0

0

0

0.50

Intact Skin

72

1

1

1

0

0

0

0.50

Abraded Skin

24

1

2

1

0

0

0

0.67

Abraded Skin

72

1

2

1

0

0

1

0.83

Subtotal

2.50

Total

4.50

Primary irritation score

1.13
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material is not irritating to the skin of rabbits under the conditions of the study. In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for skin irritation.
Executive summary:

Test Guidance

Skin irritation study performed by a similar method to 16 CFR 1500.41 of the Federal Hazardous Substances Act Regulations.

Method and Material

Six albino rabbits were clipped and then one side of the back was abraded to penetrate the stratum corneum with the other side kept intact. A 0.5 mL of the test material was applied to an abraded and an intact skin site of the same rabbit. A gauze patch was placed over each application site and an impervious material was wrapped around the trunk of the animal to hold the patches. The wrapping was removed after 24 hours. Treated areas were examined for erythema and edema using the Draize method of scoring at 24 and 72 hours.

Results

Very slight erythema was observed at the intact skin in two and three animals at 24 and 72 hours, respectively. Whereas in abraded skin, very slight erythema was observed in three and four animals at 24 and 72 hours, respectively. At 24 and 72 hours, very slight edema was observed in intact skin of three animals. At 24 and 72 hours, very slight edema was observed in abraded skin of two and three animals, respectively; whereas slight edema was observed in abraded skin of one animal at 24 and 72 hours. There was no evidence of reversibility over the limited timeframe of the study.

Conclusion

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for skin irritation.

Endpoint:
skin corrosion: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
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 conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Remarks:
In vivo testing previously conducted before in vitro rules came into force
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980-12-02 to 1980-12-09
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
details on test animals and environmental conditions not reported.
Justification for type of information:
In vivo testing previously conducted before introduction of in vitro methods.
Qualifier:
equivalent or similar to guideline
Guideline:
other: Section 1500.42- Federal Hazardous Substances Act Regulations - 16 CFR
Deviations:
yes
Remarks:
details on test animals and environmental conditions not reported
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Six albino rabbits were used in this study. A 0.1 mL of the test material was instilled into the right eyes of the test animals while the other eyes remained untreated to serve as controls. The test material was not washed from the eyes. The treated eyes were examined at 1, 2, 3, 5 and 7 days and scoring using the Draize method.
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No data
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Eyes were not rinsed throughout study
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: Draize method
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No eye irritation was observed.
Other effects:
No data

Table 7.3.2/1: Observations

Rabbit Number

Cornea

Iris

Conjunctivae

Chemosis

24 h

48 h

72 h

24 h

48 h

72 h

24 h

48 h

72 h

24 h

48 h

72 h

1

0

0

0

0

0

0

0

0

0

0

0

0

2

0

0

0

0

0

0

0

0

0

0

0

0

3

0

0

0

0

0

0

0

0

0

0

0

0

4

0

0

0

0

0

0

0

0

0

0

0

0

5

0

0

0

0

0

0

0

0

0

0

0

0

6

0

0

0

0

0

0

0

0

0

0

0

0

Mean Total

0.0

0.0

0.0

0.0
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material is not irritating to the eyes of rabbits under the conditions of the study. In accordance with EU CLP Regulation No. 1272/2008 classification of this substance is not required for eye irritation.
Executive summary:

Test Guidance

Eye irritation study performed by a similar method to 16 CFR 1500.42 of the Federal Hazardous Substances Act.

Method and Material

0.1 mL of the test material was instilled into the right eye of six young adult albino rabbits. The left eye served as the untreated control. The test material was not washed from the eye. Treated eyes were examined at 1, 2, 3, 5 and 7 days following treatment. Interpretation of results was made in accordance with the Draize scale.

Results

No sign of eye irritation was observed in any of the treated animals up to the 7 days observation period.

Conclusion

In accordance with EU CLP Regulation No. 1272/2008 classification of this substance is not required for eye irritation.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin corrosion in vitro

An in vitro skin corrosion study does not need to be conducted because adequate data from an in vivo skin irritation study are available.

 

Skin irritation in vitro

An in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available.

 

Skin irritation in vivo

The Skin irritation study was performed by a similar method to 16 CFR 1500.41 of the Federal Hazardous Substances Act Regulations.

 

Six albino rabbits were clipped and then one side of the back was abraded to penetrate the stratum corneum with the other side kept intact. A 0.5 mL of the test material was applied to an abraded and an intact skin site of the same rabbit. A gauze patch was placed over each application site and an impervious material was wrapped around the trunk of the animal to hold the patches. The wrapping was removed after 24 hours. Treated areas were examined for erythema and edema using the Draize method of scoring at 24 and 72 hours.

Very slight erythema was observed at the intact skin in two and three animals at 24 and 72 hours, respectively. Whereas in abraded skin, very slight erythema was observed in three and four animals at 24 and 72 hours, respectively. All scores were below a positive score for irritation and only three out of six animals indicate very slight erythema (grade 1) in intact skin. At 24 and 72 hours, very slight edema was observed in intact skin of three animals. At 24 and 72 hours, very slight edema was observed in abraded skin of two and three animals, respectively; whereas slight edema was observed in abraded skin of one animal at 24 and 72 hours. There was no evidence of reversibility over the limited timeframe of the study.

 

Topical range finding tests in the Buehler study conducted in accordance with OECD 406 demonstrated that the test material was well tolerated and as such, the induction exposures were performed with the neat material.

In addition, dermal irritation observations in the acute dermal toxicity study performed with rats in accordance with OECD 402 indicated no irritation with the undiluted material with a contact time of 24 hours.

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for skin irritation.

Eye irritation in vitro

An in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available.

 

Eye irritation in vivo

The eye irritation study performed by a similar method to 16 CFR 1500.42 of the Federal Hazardous Substances Act.

 

0.1 mL of the test material was instilled into the right eye of six young adult albino rabbits. The left eye served as the untreated control. The test material was not washed from the eye. Treated eyes were examined at 1, 2, 3, 5 and 7 days following treatment. Interpretation of results was made in accordance with the Draize scale.

No sign of eye irritation was observed in any of the treated animals up to the 7 days observation period.

 

In accordance with EU CLP Regulation No. 1272/2008 classification of this substance is not required 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