Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
other: read across from analogue substance
Adequacy of study:
key study
Study period:
28 March 2007 to 06 April 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study well documented, test procedure in accordance with OECD 404 methods, meets generally accepted scientific principles, acceptable for assessment. GLP compliant.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
not specified
Type of coverage:
semiocclusive
Controls:
no
Amount / concentration applied:
0.5 g of test material
Duration of treatment / exposure:
4 hours
Observation period:
up to 72 hours
Number of animals:
4 animals
Details on study design:
A single 4-hour, semi-occluded application (0.5 g) of the test material was administered to the intact skin of three rabbits. Skin reactions were recorded 1, 24, 48 and 72 hours after administration.

3 minute and 1-hour semi-occluded applications (0.5 g) of the test material were administered to the intact skin of one rabbit. Skin reactions were recorded 1,24, 48 and 72 hours after administration.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 72 h
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 72 h
Score:
ca. 0
Max. score:
8
Reversibility:
fully reversible
Irritant / corrosive response data:
non irritant
Other effects:
Skin reactions following a 4-hour exposure period: Well- defined erythema and very slght oedema were noted at one trated skin site one hour after patch removal. No evidence of skin irritation was noted at one treated skin site one hour after patch removal. No evidence of skin irritation was noted at two treated skin sites throughout the observation period or at the remaining treaed skiin site at the 24-hour observation.

Skin reactions following 3-minute and 1 hours exposure periods: black/purple-coloured staining was noted at all treated skin sites throughout the observation period.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 0.
Therefore the tested item is to be considered as non-irritant to the skin of rabbits.
Executive summary:

The primary irritation effect on analogue substance 4 was assessed following OECD 404. The result show no irritation on rabbit skin therefore the tested item is to be considered as non-irritant 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:
other: read across from analogue substance
Adequacy of study:
key study
Study period:
10 April 2007 to 07 May 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study well documented, test procedure in accordance with OECD 405 methods, meets generally accepted scientific principles, acceptable for assessment. GLP compliant.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
three male rabbits
Amount / concentration applied:
0.1 ml (95 mg) of the test material
Observation period (in vivo):
up to 21 days after administration
Number of animals or in vitro replicates:
three rabbits
Details on study design:
A single application of 0.1 ml (95 mg) of the test material was administered to the non irrigated eye of three rabbits. Ocular reactions were recorded 1, 24, 48, 72-hours, 7, 14 and 21 days after administration.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
ca. 0
Max. score:
3
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
ca. 0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
ca. 0.7
Max. score:
3
Reversibility:
fully reversible within: 3 days
Irritant / corrosive response data:
not irritant
Other effects:
The test material produced moderate conjunctival irritation. Black staining of the lower half of the cornea was noted in one treated eye throughout thestudy. Anyway, the staining did not affect evaluation of ocular effects.

Table 1: Individual and Mean Scores for Cornea, Iris and conjunctivae

 Rabbit Number  Time After Treatment  Corneal Opacity  Iridial Inflammation  Conjunctival Redness Conjunctival Chemosis 
Rabbit 1 24 hours48 hours72 hours 000  000  10 0  000
Total  0  0    0
Mean     0.0 0.0  0.3   0.0
Rabbit 2 24 hours48 hours72 hours 000  000  11 0  11 0 
Total   0
Mean   0.0 0.0  0.7  0.7 
Rabbit 3 24 hours48 hours72 hours 000  000  110  110 
Total  
Mean   0.0  0.0  0.7  0.7 
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Analogue substance 4 is considered as non-irritant to the eye of rabbits.
Executive summary:

The irritation index for analogue substance 4 was found to be 0 for the cornea, 0 for the iris and 0.7 for the conjunctivae.

The result show minimal irritation on rabbit eye following the indicated guideline but the tested item is to be considered as non-irritant to eye based on CLP criteria, table 3.2.2.7.1.

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

Additional information

Skin irritation:

The primary irritation index for analogue substance 4 as the measure of the acute irritation to the skin of rabbits was found to be 0.

Therefore the tested item is to be considered as non-irritant to the skin of rabbits.

Eye irritation:

The irritation index for analogue substance 4 was found to be 0 for the cornea, 0 for the iris and 0.7 for the conjunctivae.

The result show minimal irritation on rabbit eye following the indicated guideline but the tested item is to be considered as non-irritant to eye based on CLP criteria, table 3.2.2.7.1.

Justification for selection of skin irritation / corrosion endpoint:

Study well conducted, according to recognized method; the substance was tested at an adequate concentration to evaluate skin irritation.

Justification for selection of eye irritation endpoint:

Study well conducted, according to recognized method; the substance was tested at an adequate concentration to evaluate eye irritation.

Justification for classification or non-classification

No classification for irritation is warranted under Regulation CE 1272/2008.