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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Description of key information

The test substance is evaluated not to be irritating to the skin and not to tne mucous membranes of the eyes.

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study and GLP.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
not specified
Amount / concentration applied:
500 mg/animal
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
With physiological saline moistened test substance was applied to the shaved skin and fixed with a plaster. After the 4 h exposure time the treatment area was rinsed with water observed for 72 hours and evaluated according to Draize
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not irritating
Remarks on result:
other: not irritating
Irritant / corrosive response data:
the substance is evaluated to be non-irritating
Other effects:
-

Results:

 Time after patch removal        30 -60 min.        24 h        48 h        72 h
 Animal No:  1  2  3  1  2  3  1  2  3  1  2  3
 Formation of erythema and eschar  1  1  1  0  0  0  0  0  0  0  0  0
 Formation of edema  0  0  0  0  0  0  0  0  0  0  0  0
Executive summary:

In a skin irritation/corrosion study in rabbits according to OECD TG 404 and GLP the animals were treated with 500 mg of test substance moistened with 0.18 ml isotonic saline for 4 hours. 30 -60 minutes after patch removal in all animals a very slight erythem could be observed. After 24 hours after patch removal in all animals no irritation symptoms could be observed any more.

The test substance was evaluated to be not irritating according to directive 83/467/EWG.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: guideline study but no GLP defined.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
other: one eye of each rabbit served as control and remained untreated
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
7 d
Number of animals or in vitro replicates:
3
Details on study design:
24 hours affter application of test item into the conjunctival sac, the treated eye was rinsed with saline.
Irritation parameter:
other: according to DRAIZE
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
110
Reversibility:
fully reversible
Remarks on result:
other: not irritating
Other effects:
-

 Reading  1 h        24 h        48 h              72           
 Animal No.  19  20  21  19  20  21  19 20   21  19  20  21
 1. Cornea                        
 a) cloudiness  0  0  0  0  0  0  0  0  0  0  0  0
 b) surface  0  0  0  0  0  0  0  0  0  0  0  0
 a=A*B*5  0  0  0  0  0  0  0  0  0  0  0  0
 2. Iris  0  0  0  0  0  0  0  0  0  0  0  0
 b=A*5  0  0  0  0  0  0  0  0  0  0  0  0
 3.conjunctiva                        
 a) reddening  1  1  1  0  0  0  0  0  0  0  0  0
 b) swelling  1  1  1  0  0  0  0  0  0  0  0  0
 c) defluxion  1  1  1  0  0  0  0  0  0  0  0  0
 c=(A+B+C)*2  6  6  6  0  0  0  0  0  0  0  0  0
 Total= a+b+c  6  6  6  0  0  0  0  0  0  0  0  0

Primary irritation value: 0/9= 0.0

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

In an eye irritation study according to OECD 405 3 rabbits were treated with 0.1 g of the test substance. One eye of each test animal remained untreated and served as control. After 24 h the treated eye was flushed with with saline. The observation period was 7 d. According to DRAIZE the substance was found to be not irritating.

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

Additional information

SKIN IRRITATION

In a skin irritation/corrosion study in rabbits according to OECD TG 404 and GLP the animals were treated with 500 mg of test substance moistened with 0.18 ml isotonic saline for 4 hours. 30 -60 minutes after patch removal in all animals a very slight erythema could be observed. 24 hours after patch removal in all animals no irritation symptoms could be observed any more. Based on these observations the test substance was evaluated to be not irritating according to directive 83/467/EWG (Hofmann/Weigand 1986). Thus, the study of Hofmann/Weigand (1986) confirme the evaluation of a former skin irritation/corrosion study which was also performed according to OECD 404 (Suberg 1982) in which 3 rabbits were treated with 0.5 g of test substance fixed to the right flank of each animal for 4 h. The observation period was 7d. The untreated flank served as control. Very slight erythema and in one animal a slight and reversible edema was observed. These very slight irritational effects do not lead to classification and therefore the test substance was evaluated to be not irritating.

EYE IRRITATION

In an eye irritation study according to OECD 405 3 rabbits were treated with 0.1 g of the test substance. One eye of each test animal remained untreated and served as control. After 24 h the treated eye was flushed with saline. The observation period was 7 d. According to DRAIZE the substance was found to be not irritating (Suberg H., Bayer AG, 1982). An additional eye irritation study which was also performed according to OECD guideline 405 and GLP (Hofmann/Weigand 1986), confirmed this result.


Justification for selection of skin irritation / corrosion endpoint:
The study was performed according to guideline and GLP and evaluated with Klimisch score 1

Justification for selection of eye irritation endpoint:
a carefully reported guideline study but no GLP mentioned

Justification for classification or non-classification

Based on the available data no classification/labelling is required.