Registration Dossier

Administrative data

Description of key information

Two GLP and OECD guideline conform studies (OECD 404 and 405) were conduceted to evaluate the irritating potential of the

test item. As a result, the material is not irritating to skin or eyes. Clinical signs or mortalities were not observed.

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:
2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Elevage Scientifique des Dombes, Chatillon sur Chalaronne / France- Age at study initiation: 10 weeks (male), 10 weeks (females)- Weight at study initiation: 1802 g (male); 2104 g (female), 2310 g (female)2310- Housing: Individually- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 93/01) provided by Provimi Kliba AG, Kaiseraugst.- Water (e.g. ad libitum): Community tap water from Fullinsdorf, ad libitum- Acclimation period: 6 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 17-23- Humidity (%): 30-70- Air changes (per hr): 10-15- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE- Area of exposure: 4 cm x 4 cmREMOVAL OF TEST SUBSTANCE- Washing (if done): flushed with lukewarm tap waterSCORING SYSTEM: Driaze scoring system
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Interpretation of results:
GHS criteria not met
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:
2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS- Source: Elevage Scientifique des Dombes, Chatillon sur Chalaronne / France- Age at study initiation: 14 weeks (male), 12-13 weeks (females)- Weight at study initiation: 2398g (male), 2742 g (female), 2681 g (female)- Housing: Individually- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 93/01) provided by Provimi Kliba AG, Kaiseraugst.- Water (e.g. ad libitum): Community tap water from Fullinsdorf, ad libitum- Acclimation period: 6 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 17-23- Humidity (%): 30-70- Air changes (per hr): 10-15- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.1 g/animal
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize scoring systemTOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp (A. Riegger, Basel / Switzerland)
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
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
Remarks on result:
other: Redness was observed after one hour.
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: one hour
Remarks on result:
other: Slight redness was observed after one hour.
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Redness was observed after one hour.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Slight redness was observed after one hour in 2 animals.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There are reliable studies available to assess the potential of the substance for skin and eye irritation.

 In a GLP conform study the primary skin irritation potential of the test substance (purity: > 98 weight-%) was investigated by topical semi-occlusive application of 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits (RCC Ltd, 2002). The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0. The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any measuring interval. The test substance is considered to be "not irritating" to rabbit skin.

In a GLP conform study the primary eye irritation potential of the test substance (purity: > 98 weight-%) was investigated by instillation of 0.1 g into one eye of each of three young adult New Zealand White rabbits (RCC Ltd, 2002). Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test item application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion. The primary eye irritation score was calculated by totaling the mean cumulative scores at 24, 48 and 72 hours and then dividing the resulting total by the number of data points. The primary eye irritation score was 0.33 (max. 13). The eye reactions (mean values from 24 to 72 hours) consisted of grade 0.00 corneal opacity, grade 0.00 iris lesions, grade 0.33 redness of the conjunctivae and grade 0.00 chemosis of the conjunctivae. The instillation of the test substance into the eye resulted in mild, early-onset and transient ocular changes, such as swelling and reddening of the conjunctivae and sclerae. These effects were reversible and were no longer evident 72 hours after treatment, the end of the observation period for all animals. No abnormal findings were observed in the cornea or iris of any animal at any reading. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed. Thus, the test item did not induce significant or irreversible damage to the rabbit eye. The test substance is considered to be "not irritating" to the rabbit eye.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) 1272/2008. Based on this data the substance does not need to be classified for irritation under Regulation (EC) No. 1272/2008.