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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 OECD 404, rabbit, 4 h, semiocclusive: not irritating 
Eye irritation OECD 405, rabbit, 24 h, not rinsed: not irritating

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: GLP guideline study.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, 88353 Kißlegg, Germany
- Age at study initiation: young adults
- Weight at study initiation: 2.5-2.7 kg
- Housing: individually in cage units Metall Noryl by EBECO; excrement trays below the cages contained low dust wood granulate bedding.
- Diet (e.g. ad libitum): standard diet "Ssniff K-Z" 4mm (manufacturer: Ssniff Spezialdiaeten GmbH, 59494 Soest, Germany), approximately 100 g per animal per day
- Water (e.g. ad libitum): tap water ad libitum from polycarbonate bottles
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 50±25
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g, moistened with water to ensure good contact with the skin.
Duration of treatment / exposure:
3 min, 1 hour, 4 hours
Observation period:
1, 24, 48, 72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: rigt and left side of the dorso-lateral area of the trunk of each rabbit were shorn on the day before the test
- Type of wrap if used: moistened substance was applied to the skin under a gauze patch (treated area approx. 2.5x2.5 cm in size). The patch was held in place with non-irritating tape for the duration of the exposure period

REMOVAL OF TEST SUBSTANCE
- Washing: yes, carefully washed with water without altering the existing response or the integrity of the epidermis.
- Time after start of exposure: 3 min, 1 hour, 4 hours

SCORING SYSTEM: Draize, the surrounding untreated skin served as control.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritant / corrosive response data:
After 3 min and 1 hour exposure time no effects were observed. After exposure for 4 hours very slight erythema (barely perceptible) was observed in one animal which completely reversed until the 48-hour reading. The other animals did not show any effects.
Other effects:
No signs of systemic toxicity were observed.

According to the criteria of Directtive 67/548/EEC and Regulation (EC) No 1272/2008 the test substance does not have to be classified as irritating to the skin.

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River, 88353 Kißlegg, Germany
- Age at study initiation: young adults
- Weight at study initiation: 2.4-2.5 kg
- Housing: individually in cage units Metall Noryl by EBECO; excrement trays below the cages contained low dust wood granulate bedding.
- Diet (e.g. ad libitum): standard diet "Ssniff K-Z" 4mm (manufacturer: Ssniff Spezialdiaeten GmbH, 59494 Soest, Germany), approximately 100 g per animal per day
- Water (e.g. ad libitum): tap water ad libitum from polycarbonate bottles
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 50±25
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eyes served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g of the pulverised substance
Duration of treatment / exposure:
Not washed out
Observation period (in vivo):
1, 24, 48, 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: Draize
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritant / corrosive response data:
One hour after application the test compound adhered to the corneae and conjunctivae of all animals. Redness of the conjunctivae of grade 2 was observed in 2/3 animals and of grade 1 in the third animal. This redness completely reversed until the 24h-reading in 2 of the animals and until the 48h-reading in the third animal. No other irritant effects were observed.
Other effects:
There were no signs of systemic effects.

According to the criteria of Directive 67/548/EEC and Regulation (EC) No 1272/2008 the test material does not have to be classified as irritating to the eyes.

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

There is a GLP-study available performed in 2006 assessing the irritative effects of the test substance to the skin. The test was performed in 3 New Zealand White rabbits which were exposed for 4 hours to the test substance under semiocclusive conditions, according to OECD guideline 404. Additional exposure times of 3 minutes and 1 hour were included to assess corrosivity. There were no effects observed after 3 minutes and 1 hour exposure time. After semiocclusive exposure for 4 hours a very slight edema (barely perceptible) was observed in one animal 24 hours after exposure which completely reversed within 48 hours. The other animals did not show any irritative effects; there were no signs of systemic toxicity.

The study assessing the irritative effects of the test substance to the eyes was also performed in 2006 under GLP-conditions, according to OECD guideline 405. One eye each of three New Zealand White rabbits was treated with 0.1 g of the pulverised test substance which was not washed out, and observations were conducted 1, 24, 48 and 72 hour(s) after application. One hour after application the test compound adhered to the corneae and conjunctivae of all animals. Redness of the conjunctivae of varying grade was observed in all animals, probably due to the mechanical irritation, which had completely reversed 24 hours after application in two animals and 48 hours after application in the third animal. No other irritant effects were observed; there were no signs of systemic toxicity.

Justification for classification or non-classification

According to the criteria of Regulation (EC) No 1272/2008 the test substance does not have to be classified as irritating to the skin or the eyes.