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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin irritation/corrosion: no skin irritation or severe skin burns and eye
damage
The test material is not irritating to skin. This conclusion is legitimate even though the applied testing regime differs from today's standard methods. Since the test conditions were more stringent than required by OECD TG 404 (i.e. 24 h treatment, occlusive coverage, and scarified skin instead of 4 h treatment, semi-occlusive coverage, and intact skin) the test results are considered adequate to fulfill the endpoint requirements.
1/6 animals showed a score of 1 for edema in the 24 h reading. This effect was completely reversible within 48 h after removal of the test item.

Eye irritation: no serious eye irritation or damage


The test material was not irritating to eyes in all animals under test conditions which are basically in accordance with todays standard methods regarding dosing, exposure duration, scoring system and reading time points.

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973)
Deviations:
no
Principles of method if other than guideline:
As compared to current guidelines deviations are: 24 h treatment and occlusive coverage, instead of 4 h treatment and semi-occlusive coverage. Mean scores for each animal were claculated from the readings 0, 24, and 48 h after the end of treatment.

Since test conditions were more stringent than required by OECD TG 404 test results are considered adequate to fulfill the endpoint requirements.
GLP compliance:
no
Remarks:
not established at that time
Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Frankfurt, Germany
- Weight at study initiation: 1.5 - 2.5 kg
- Housing: single
- Diet: standard diet (ERKA 8300, Futtermittelwerke Robert Koch , Hamm. Germany), ad libitum
- Water: ad libitum
Type of coverage:
occlusive
Preparation of test site:
other: clipped, partially scarified
Vehicle:
physiological saline
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 500 mg pasted with 0.7 ml physiol. saline.
Duration of treatment / exposure:
24 h
Observation period:
48 h after end of exposure
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm gauze patch
- Type of wrap if used: PVC foil, elastic bandage

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

SCORING SYSTEM: described in § 1500.41 in Fed. Reg. 38, No. 187, 27.09.1973, p. 27019, in accordance with OECD TG 404.
Scores were assessed 24, 48 and 72 h after start of exposure, which lasted for 24 h. For classification, the readings are stated here as immediately, 24 and 48 h after end of exposure.
Irritation parameter:
erythema score
Basis:
animal: # 1, 2, 3, 4, 5, 6 each
Time point:
other: mean of the 0, 24 and 48 h reading
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effect
Remarks on result:
other: Scores of intact skin. Readings took place 0, 24 and 48 h after end of treatment. Means thereof were claculated for each rabbit.
Irritation parameter:
edema score
Basis:
animal: # 1,2,3,5,6 each
Time point:
other: mean of the 0, 24 and 48 h reading
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effect
Remarks on result:
other: Scores of intact skin. Readings took place 0, 24 and 48 h after end of treatment. Means thereof were claculated for each rabbit.
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: mean of the 0, 24 and 48 h reading
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: Scores of intact skin. Readings took place 0, 24 and 48 h after end of treatment. Means thereof were claculated for each rabbit.
Irritant / corrosive response data:
- Edema score for animal #1,2,3,4,5,6 immediately after removal of the test item (0 h): 0,0,0,1,0,0 and after 24 h: 0,0,0,1,0,0, and after 48 h: 0,0,0,0,0,0 (intact skin).

- At the scarified skin two animals showed erythema (score 1) 24 h after end of exposure, 3 animals showed edema at the end of the exposure period (score 1) and 1 animal showed edema score 1 at 24 h after end of exposure, these effects were completely reversible at the reading 48 h after end of exposure.
Interpretation of results:
not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test material is not irritating to skin. This conclusion is legitimate even though the applied testing regime differs from today's standard methods. Since the test conditions were more stringent than required by OECD TG 404 (i.e. 24 h treatment, occlusive coverage, and scarified skin instead of 4 h treatment, semi-occlusive coverage, and intact skin) the test results are considered adequate to fulfill the endpoint requirements.
1/6 animals showed a score of 1 for edema in the 24 h reading. This effect was completely reversible within 48 h after removal of the test item.
Executive summary:

The test material was tested for skin irritancy according to FDA guidelines. Both intact and scarified skin sites of six rabbits were exposed to 0.5 g test substance for 24 h under occlusive conditions and the skin responses were watched for 48 hours after end of exposure. Only slight effects could be observed (1/6 animals showed a edema score of 1 in the 24 h reading, which was completely reversible in the 48 h reading.

No erythema effects could be observed in any animal.

Therefore, it is concluded that the test item is not irritating to skin.

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973)
Deviations:
no
GLP compliance:
no
Remarks:
not established at that time
Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Frankfurt, Germany
- Weight at study initiation: 1.5 - 2.5 kg
- Housing: single
- Diet: standard diet (ERKA 8300, Futtermittelwerke Robert Koch , Hamm. Germany), ad libitum
- Water: ad libitum
Vehicle:
physiological saline
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 100 mg pasted with 0.25 ml physiol. saline.
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: with physiological saline
- Time after start of exposure: 24 h

SCORING SYSTEM: basically in accordance with OECD TG 405.
Scores were read 1, 7, 24, 48 and 72 h after test substance application.

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein at 48 and 72 h reading
Irritation parameter:
cornea opacity score
Basis:
animal: # 1, 2, 3, 4, 5, 6 each
Time point:
other: mean of the 24, 48 and 72 h reading
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effect
Remarks on result:
other: Readings took place 24, 48 and 72 h after instillation. Means thereof were claculated for each rabbit.
Irritation parameter:
iris score
Basis:
animal: # 1, 2, 3, 4, 5, 6 each
Time point:
other: mean of the 24, 48 and 72 h reading
Score:
0
Max. score:
2
Reversibility:
other: reversibility not relevant since no effect
Remarks on result:
other: Readings took place 24, 48 and 72 h after instillation. Means thereof were claculated for each rabbit.
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: # 1, 2, 3, 4, 5, 6 each
Time point:
other: mean of the 24, 48 and 72 h reading
Score:
0
Max. score:
3
Reversibility:
other: reversibility not relevant since no effect
Remarks on result:
other: Readings took place 24, 48 and 72 h after instillation. Means thereof were claculated for each rabbit.
Irritation parameter:
chemosis score
Basis:
animal: # 1, 2, 3, 4, 5, 6 each
Time point:
other: mean of the 24, 48 and 72 h reading
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effect
Remarks on result:
other: Readings took place 24, 48 and 72 h after instillation. Means thereof were claculated for each rabbit.
Irritant / corrosive response data:
- no effects were observed at any time point.
- no discharge was observed.
Interpretation of results:
not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test material was not irritating to eyes in all animals under test conditions which are basically in accordance with todays standard methods regarding dosing, exposure duration, scoring system and reading time points.
Executive summary:

Test material was subject to a test of eye irritancy according to FDA guidelines (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973). 100 mg of substance were applied to one eye of each of six animals. The eyes were washed 24 h after application and eye responses were noted for 72 h. No responses of the eyes were observed within 72 hours after application. Therefore, it is concluded that the submission substance is not irritating to eyes.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
most up to date and most reliable study available

Justification for selection of eye irritation endpoint:
most up to date and most reliable study available

Justification for classification or non-classification

All mean scores determined for skin and eye irritation were markedly below the threshold for classification. Furthermore no signs of corrosive properties were observed. Thus the substance subject to registration does not meet criteria for classification according to REGULATION (EC) No 1272/2008.