Registration Dossier

Administrative data

Description of key information

Skin irritation/corrosion (OECD 404, GLP, RL1), rabbit: not irritating
Eye irritation (OECD 405, GLP, RL1), rabbit: 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
Study period:
04 March 2002 to 29 April 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
FREIE UND HANSESTADT HAMBURG; BEHÖRDE FÜR ARBEIT, GESUNDHEIT UND SOZIALES, Germany
Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology KG
- Age at study initiation: 3.5-4 months
- Weight at study initiation: 1.9-2.0 kg
- Housing: Individually in cages measuring 425x600x380 mm
- Diet: ssniff K-H (ssniff Spezialdiäten GmbH, Soest, Germany; analysed for contaminants at least twice a year), ad libitum
- Water: tap water (analysed for contaminants at least twice a year), ad libitum
- Acclimation period: At least 20 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 55±15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From 09 April 2002 to 29 April 2002
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 ml
Duration of treatment / exposure:
4 h
Observation period:
96 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: Semi-occlusive

REMOVAL OF TEST SUBSTANCE
- Washing: No

SCORING SYSTEM: Draize scoring system
Irritation parameter:
erythema score
Basis:
animal: #1 and #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 96 h
Remarks on result:
other: At any time point the erythema score was 1.
Irritation parameter:
edema score
Basis:
mean
Remarks:
over all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
Animals 1 and 2 showed no signs of irritation at any time point. Animal 3 had an erythema (grade 1) from 60 minutes up to 72 hours after patch removal.
Other effects:
There were no other effects reported.
Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
Conclusions:
The test item was tested for skin irritation/corrosion according to the OECD TG 404 and in complinance with GLP. Minor erythema (score 1) was observed in one out of three animals, which was reversible within 96 hours. Hence, the test item was found to be not irritating and classification according to 67/584/EEC and EC/1272/2008 is not warranted.
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:
22 October 1991 to 01 November 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventionell bred
- Age at study initiation: 3-5 months
- Weight at study initiation: 3.1-3.3 kg
- Housing: in individual cages (battery housing)
- Diet: Altromin 2123 Haltungsdiät - Kanninchen (Altromin GmbH, Lage/Lippe, Germany), ad libitum; and 15 g hay daily
- Water: deionised and chlorised water, ad libitum, provided in automated drinking troughs

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±3
- Humidity (%): 55±20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 22 October 1991 to: 01 November 1991
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
24 h
Observation period (in vivo):
reading time pointr: 1, 24, 48, and 72 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: with physiol. NaCl solution at 37 °C
- Time after start of exposure: after 24 h and at every reading time point, when dicharge was observed or the eyes were determined for corneal damage using fluorescein

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
over all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
over all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
over all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
One hour after exposure the conjunctivae had diffuse redness and partial eversion of the eyelids. After 24 hours two animals had marked hyperaemia. After 48 hours the irritation had reversed.
Other effects:
None reported.
Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
Conclusions:
The test item was tested for eye irritation according to the OECD TG 405 and in compliance with GLP. One hour after exposure the conjunctivae had diffuse redness and partial eversion of the eyelids. After 24 hours two animals had marked hyperaemia (grade 2). One animal fully recovered within 24 h, the other two animals fully recovered within 48 h. Based on these findings classification according to 67/584/EEC and EC/1272/2008 is not warranted.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion:

In the available key study the test item (91.5% pure) was tested for eye irritation according to the OECD TG 404 and in compliance with GLP (LPT, 2002b). 0.5 ml of the test material was applied to the shaved, intact skin of three Himalayan rabbits and was covered using a semi-occlusive dressing for four hours. After four hours the dressing was removed and no washing was required. An erythema (grade 1) was observed in one animal from 60 minutes up to 72 hours after the patch removal. There were no substance-related changes at the examination time points of 1, 24, 48 and 72 hours for the other two animals. There were no signs of systemic toxicity. Hence, the test item was considered non-irritating to the skin.

Eye irritation:

In the available key study the test item was tested for eye irritation according to the OECD TG 405 and in compliance with GLP (Hoechst, 1991). Three New Zealand White rabbits received the unchanged test material, which was rinsed off the eyes 24 hours after instillation. One hour after exposure the conjunctiva had diffuse redness and partial eversion of the eyelids (conjunctival score = 2) in all animals. After 24 hours two animals still had marked hyperaemia (conjunctival score = 1) that were fully reversible within 48 h. Thus, the mean score over 24, 48 and 72 h out of all 3 animals for conjunctival redness is 0.2. Scores for cornea, iris, and chemosis were 0 at any reading time points in all animals. Based on these findings classification for eye irritation is not warranted.


Justification for classification or non-classification

The available data on skin and eye irritation are reliable and suitable for classification. Based on this data, classification for skin irritation/corrosion and eye irritation according to 67/584/EEC and EC/1272/2008 is not warranted.