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Diss Factsheets

Administrative data

Description of key information

Skin irritation

Key, rabbit, OECD 404, GLP, negative

Eye irritation

Key, rabbit, OECD 405, GLP, negative

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:
23 MAR 2007 - 13 JUL 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to OECD TG 404.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
24 April 2002
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 Wiga GmbH, Kißlegg
- Age at study initiation: 37 weeks
- Weight at study initiation: 4.82 kg
- Housing: Animals were kept separately in special rabbit cages (manufacturer: Becker; type K99/30 KU). The collection pans underneath the cages were cleaned at least three times per week.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 -19 °C
- Humidity (%): 45 - 53 %
- Photoperiod (hrs dark / hrs light): 12 / 12 hours

IN-LIFE DATES: From: To: day 1 day 8
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: aqua pro injectione
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g mixed with some droplets aqua pro injectione spread on 6 cm²

VEHICLE
- Amount(s) applied (volume or weight with unit): some drops
- Lot/batch no. (if required): 189
Duration of treatment / exposure:
4 hours
Observation period:
1 hour after removal of the patches, after 24, 48, 72 hours, and then daily up to experimental day 8.
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- % coverage: 100 %
- Type of wrap if used: self-adhesive fabric (Fixomull® stretch, Beiersdorf)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no (wiped off)
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize scoring system
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Under the conditions of the present study no signs of irritation were seen.
Other effects:
Symptoms
No signs of clinical toxicity were detected.

Mortality
All animals survived the observation period.

Body weight
Body weight development of the treated rabbits was inconspicuous.
Interpretation of results:
other: EU GHS criteria not met
Conclusions:
Under the conditions of the present study no signs of irritation were seen.
Executive summary:

The current study was performed under GLP-compliance according to the OECD Guideline for Testing of Chemicals, No. 404 and the recommendations of DRAIZE (1959). To test for primary skin irritation, 0.5 g of the test material was mixed with some drops of Aqua pro injectione to ensure good contact with the skin. Afterwards the test material was spread onto 6 cm² patches and applied to the intact skin of previously shaven rabbits for a 4 hours period under semi-occlusive conditions. The study was started as an initial test with one animal and followed by the confirmatory test with two further animals. The first examination of the treated skin sites followed 1 hour after removal of the patches. Thereafter, examinations were performed daily for further 7 days. Under the conditions of the present study no signs of irritation were seen.


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:
5 JUN - 23 AUG 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to OECD TG 405.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
24 April 2002
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 Wiga GmbH, Kißlegg
- Age at study initiation: 14- 15 weeks
- Weight at study initiation: 3.31 kg
- Housing: separately in special rabbit cages (manufacturer: Becker; type K99/30 KU). The collection pans underneath the cages were cleaned at least three times per week.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: > 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 22 °C
- Humidity (%): 44 to 84 %.
- Photoperiod (hrs dark / hrs light): 12 / 12 hours

IN-LIFE DATES: From: day 1 To: day 8
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
After instillation, the eyelids were closed for 30 seconds.
Observation period (in vivo):
24, 48, and 72 hours, then daily up to day 8 of the experimental part
Number of animals or in vitro replicates:
3 female rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Eye changes were evaluated according to DRAIZE, OECD and EEC recommendations.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of irritation were observed at the cornea or iris. All animals showed redness (score 1) and chemosis (score 1) one hour after instillation of the test material. Discharge (score 1-2) occurred in two animals 1 hour after instillation and in one animal 1 hour after instillation of the test material and on day 2 of the experimental part. No abnormalities were detected in the untreated eyes.
Other effects:
Mortality
All animals survived the observation period.

Body weight
Body weight development of the treated rabbits was inconspicuous.

Clinical findings
No signs of clinical toxicity were detected.
Interpretation of results:
other: EU GHS criteria not met
Conclusions:
No signs of irritation were observed at the cornea or iris. All animals showed redness (score 1) and chemosis (score 1) one hour after instillation of the test material. Discharge (score 1-2) occurred in two animals 1 hour after instillation and in one animal 1 hour after instillation of the test material and on day 2 of the experimental part. No abnormalities were detected in the untreated eyes.
Executive summary:

The test material was studied for its eye irritating properties in rabbits. The study was performed according to OECD Guideline 405 following GLP. The test was performed initially with one animal and followed by the confirmatory test with two further animals. The test material was applied into the conjunctival sac of rabbits. The first examination of the eyes followed 1 hour after instillation. The other examinations of the eyes were performed daily for further 7 days. No signs of irritation were observed at the cornea or iris. All animals showed redness (score I) and chemosis (score I) one hour after instillation of the test material. Discharge (score 1- 2) occurred in two animals 1 hour after instillation and in one animal 1 hour after instillation of the test material and on day 2 ofthe experimental part. No eye irritating potential could be detected.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

The current study was performed under GLP-compliance according to the OECD Guideline for Testing of Chemicals, No. 404 and the recommendations of DRAIZE (1959). To test for primary skin irritation, 0.5 g of the test material was mixed with some drops of Aqua pro injectione to ensure good contact with the skin. Afterwards the test material was spread onto 6 cm² patches and applied to the intact skin of previously shaven rabbits for a 4 hours period under semi-occlusive conditions. The study was started as an initial test with one animal and followed by the confirmatory test with two further animals. The first examination of the treated skin sites followed 1 hour after removal of the patches. Thereafter, examinations were performed daily for further 7 days. Under the conditions of the present study no signs of irritation were seen.

Eye irritation

The test material was studied for its eye irritating properties in rabbits. The study was performed according to OECD Guideline 405 following GLP. The test was performed initially with one animal and followed by the confirmatory test with two further animals. The test material was applied into the conjunctival sac of rabbits. The first examination of the eyes followed 1 hour after instillation. The other examinations of the eyes were performed daily for further 7 days. No signs of irritation were observed at the cornea or iris. All animals showed redness (score I) and chemosis (score I) one hour after instillation of the test material. Discharge (score 1- 2) occurred in two animals 1 hour after instillation and in one animal 1 hour after instillation of the test material and on day 2 ofthe experimental part. No eye irritating potential could be detected.


Justification for classification or non-classification

Based on the result of the available studies, the registered substance is not subject to classification in accordance with Regulation (EC) No 1272/2008.