Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

No skin or eye irritating effects were noted.

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:
1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
other: HC: NZW
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK Ltd
- Weight at study initiation: 3.4 - 3.6 kg
- Housing: individual mesh cages, Type III
- Diet (e.g. ad libitum): ssniff K4, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 14 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 45-65%
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
The duration of exposure was 4 h. The treated area was washed with water after end of exposure period.
Observation period:
24, 48 and 72 h after removal of the patches.
Number of animals:
3 females
Details on study design:
TEST PROCEDURE
About 24 h before the start of the study the hair in the contralateral sides of the dorsal region of the body of 3 rabbits was removed with an electric clipper over an area of about 6 cm2. Only animals with intact skin were used.

Each animal was treated with 0.5 g test substance in water. The substance was applied over the whole surface of a 6 x 6 cm patch on a piece of surgical plaster (i.e. specially produced by BeierSdorf Aktiengesellschaft). The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.

The exposure period was 4 h. After the exposure period all remnants of the test substance were carefully removed from the skin with water.

Examinations of the skin took place 24, 48 and 72 h after removal of the patches.

Erythema, eschar formation and edema were evaluated numerically according to the Draize scoring system. All other changes of the skin were recorded.

SCORING SYSTEM:

Erythema and eschar formation
No erythema........................................................................................................................0
Very slight erythema (barely perceptible) ......................................................................1
Well-defined erythema ......................................................................................................2
Moderate to severe erythema............................................................................................3
Severe erythema (beet redness) to eschar formation (injuries in depth) preventing
grading of erythema...........................................................................................................4

Edema - swelling
No edema..............................................................................................................................0
Very slight edema (barely perceptible).............................................................................1
Slight edema (edges of area well defined by definite raising).......................................2
Moderate edema (raised approximately 1 mm) ..............................................................3
Severe edema (raised more than 1 mm and extending beyond area of exposure)...4
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the test substance was considered to be non-irritating to rabbit skin.
Executive summary:

A study was performed to assess the skin irritation potential of the test substance in female New Zealand albino rabbits according to OECD Guideline 404, in compliance with GLP. 500 mg of the test substance pasted with water was evenly applied over the whole surface of a 6 x 6 cm cellulose patch on a piece of surgical plaster. The plaster was fixed to the prepared skin area of about 6 cm² and then covered with a semi-occlusive bandage. The patch was allowed to remain in contact with the skin for 4 h. After the exposure period, all remnants of the test substance were carefully removed with warm tap water. Animals were scored for irritation reactions after 24, 48 and 72 h. No signs of irritation were observed during the whole observation period. Overall mean scores for dermal irritation were calculated to be 0.0 for erythema and eschar formation and 0.0 for edema formation. Under the test conditions, the test substance was considered to be non-irritating to rabbit skin (Ruf, 1987a).

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:
1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
other: HC: NZW
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK Ltd
- Weight at study initiation: 3.1 - 3.7 kg
- Housing: individual mesh cages, Type III
- Diet (e.g. ad libitum): ssniff K4, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 14 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 45-65%
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
40 mg in 100 µL
Duration of treatment / exposure:
Duration of exposure was 24 h. The treated eye was rinsed with saline solution at the end of the exposure period.
Observation period (in vivo):
1, 24, 48 , 72 h and after 7, 14 and 21 d following administration of the test substance.
Number of animals or in vitro replicates:
3 females
Details on study design:
TEST PROCEDURE

40 mg of the test substance was administered once to the conjunctival sac of the left eye of the rabbits in 100 µL solution. In each case the untreated eye served as a control. 24 h after administration, the treated eye was washed out thoroughly with saline solution.

The eyes were examined 1, 24, 48 , 72 h and after 7, 14 and 21 d following administration of the test substance for effects on the cornea, iris and conjunctiva. Scoring was done according to the Draize scale. Tear production and any effects not covered by the Draize scale were also recorded.

In case of positive findings in the iris and cornea at 24 h and at later evaluation points, one drop of a 1% fluorescein solution was applied to the corneal surfaces, then washed out with saline solution. The eyes were thereafter analysed with UV light.
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Remarks:
(mean score)
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Remarks:
(mean score)
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Remarks:
(mean score)
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Slight redness or redness and swelling of the conjunctivae were seen in the rabbits in the first 24 h after administration of the test substance. These effects were linked to mechanical irritation.
Other effects:
Slight tear production was seen in one rabbit at the 24 h observation point.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the test substance was not considered to be irritating to the rabbit eyes.
Executive summary:

A study was conducted to assess the eye irritation potential of the test substance in one New Zealand albino female rabbit according to OECD Guideline 405, in compliance with GLP. A single dose of 40 mg test substance was applied to the conjunctival sac of the left eye of the animal in 100 µL solution. The treated eye was washed at 24 h after administration. The untreated eye served as a control. The eyes were examined 1, 24, 48 , 72 h and after 7, 14 and 21 d following administration of the test substance for effects on the cornea, iris and conjunctiva. Scoring was done according to the Draize scale. Tear production and any effects not covered by the Draize scale were also recorded. Slight redness or redness and swelling of the conjunctivae were seen in the rabbits in the first 24 h after administration of the test substance. One rabbit showed light tear production at 24 h. These effects were linked to mechanical irritation and were reversible before end of the study. Under the test conditions, the test substance was not considered to be irritating to the rabbit eyes (Ruf, 1987b).

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin

A study was performed to assess the skin irritation potential of the test substance in female New Zealand albino rabbit according to OECD Guideline 404, in compliance with GLP. 500 mg of test substance pasted with water was evenly distributed over the whole surface of a 6 x 6 cm cellulose patch on a piece of surgical plaster. The plaster was fixed to the prepared skin area of about 6 cm² and then covered with a semi-occlusive bandage. The patch was allowed to remain in contact with the skin for 4 h. After the exposure period, all remnants of test substance were carefully removed with warm tap water. Animals were scored for irritation reactions after 24, 48 and 72 h. No signs of irritation were observed during the whole observation period. Overall mean scores for dermal irritation were calculated to be 0.0 for erythema and eschar formation and 0.0 for edema formation. Under the test conditions, the test substance was considered to be non-irritating to skin (Ruf, 1987a).

Eyes

A study was conducted to assess the eye irritation potential of the test substance in one New Zealand albino female rabbit according to OECD Guideline 405, in compliance with GLP. A single dose of 40 mg test substance was applied to the conjunctival sac of the left eye of the animal in 100 µL solution. The treated eye was washed at 24 h after administration. The untreated eye served as a control.The eyes were examined 1, 24, 48 , 72 h and after 7, 14 and 21 d following administration of the test substance for effects on the cornea, iris and conjunctiva. Scoring was done according to the Draize scale. Tear production and any effects not covered by the Draize scale were also recorded. Slight redness or redness and swelling of the conjunctivae were seen in the rabbits in the first 24 h after administration of the test substance. These effects were linked to mechanical irritation and reversible before end of the study. Under the test conditions, the test substance was not considered to be irritating to the eyes (Ruf, 1987b).

Justification for classification or non-classification

Based on the results of in vivo studies, no classification for skin and eye irritation is warranted for the test substance according to CLP (EC/1272/2008) criteria.