Registration Dossier

Administrative data

Description of key information

The test substance did not cause skin irritation on the rabbit skin. Neither erythema nor edema were evident. No effects in the rabbit eye caused by the substance were evident, either. (reliability score: 2)

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (limited documentation, no data on test substance purity, occlusive conditions, 24 h exposure)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(limited documentation, occlusive treatment, 24 h exposure, no scoring at 48 h))
Principles of method if other than guideline:
6 rabbits were treated with 0.5 g of the test substance, prepared as paste with diethyl succinate, for 24 h under occlusive conditions. The test sites were shaved before treatment. The test substance was applied to intact as well as to abraded skin. Scoring was recorded 24 h and 72 h after application (Draize Test).
GLP compliance:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): Ultraviolet Absorber P-541; Cyasorb UV-5411; 2-(2'-Hydroxy-5'-tert-octylphenyl) benzotriazole
- Physical state: solid
- Analytical purity: no data
Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
no data
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: diethyl succinate
Controls:
other: untreated site served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g

Duration of treatment / exposure:
24 h
Observation period:
no data
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: no data
- Type of wrap if used: impervious patch

REMOVAL OF TEST SUBSTANCE
- Washing: no data
- Time after start of exposure: 24 h

SCORING SYSTEM: according to the Draize Scoring System
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of 6 animals
Time point:
other: mean over 24 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: intact and abraded skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of 6 animals
Time point:
other: mean over 24 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: intact and abraded skin
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (limited documentation, no data on test substance purity)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(limited documentation, no information on observation period)
Principles of method if other than guideline:
0.1 g of the unchanged test substance was introduced into the conjunctival sac of 6 rabbits. Scoring was recorded 24 h, 48 h and 72 h after application (Draize Test).
GLP compliance:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): Ultraviolet Absorber P-541; Cyasorb UV-5411; 2-(2'-Hydroxy-5'-tert-octylphenyl) benzotriazole
- Physical state: solid
- Analytical purity: no data
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data
Vehicle:
unchanged (no vehicle)
Controls:
other: the adjacent eye served as control
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
one single application
Observation period (in vivo):
no data
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no data

SCORING SYSTEM: according to the Draize Scoring System
(no chemosis scores were documented)
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Other effects:
Chemosis score was not taken, but was normally included in the conjunctivae score.
Furthermore, the following information was given: No obvious swelling of the conjunctivae excluding cornea and iris with partial eversion of the lids was seen.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation

In a primary dermal irritation study, performed using a method identical to that described in the Federal Register, 38, No. 187 § 1500.41, 0.5 g of the test substance (no data on purity) was applied under occlusive conditions to the intact and abraded skin of 6 Albino rabbits. Treatment was terminated 24 hours following application and the animals were observed afterwards (no data on duration of observation period). Irritation was scored according to the Draize method 24 and 72 hours after application.

Average scores per animal (24 h – 72 h) were 0 (maximal score = 4). No signs of skin irritation were evident by the end of the observation period.

Results from the abraded skin are not included in the final judgement for skin irritation of the test substance because of its lack of scientific justification and gross deviation from todays acceptable standardized procedures for the appraisal of skin irritation. In this study, the test substance is not a skin irritant.

 

This study is suitable for assessment of dermal irritation as it was performed using a protocol which is similar and equivalent to the OECD guideline. The conditions are even harsher (occlusive, extended exposure) than that described by the actual OECD guideline.

 

 

Eye irritation

The eye irritation potential of the test substance (no data on purity) was determined in a procedure identical to the procedure described in the Federal register 38, No. 187 § 1500.42, 0.1 g of the test substance was applied to the conjunctival sac of the left eye of each of 6 Albino rabbits. The other eye remained untreated and served as control. Irritation was recorded after 24, 48 and 72 hours. Appraisal of eye irritation was performed according to the method of Draize. Average Draize scores (24, 48 and 72 hours) were calculated per animal for corneal opacity, iritis, conjunctivae redness and chemosis. No indication for eye irritation was seen in any animal. All scored parameters in the 6 animals were 0. In this study, the test substance is not an eye irritant.

 

This study is suitable for assessment of eye irritation as it was performed using a protocol which is similar and equivalent to the OECD guideline.

Justification for classification or non-classification

Dangerous substance Directive (67/548/EEC)

The available experimental test data are considered reliable and suitable for the purpose of classification. Based on the criteria for classification of skin irritants of Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC, classification for skin and eye irritation is not warranted.

 

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for the purpose of classification. Based on the criteria laid down in Regulation (EC) No. 1272/2008, as amended for the fifth time in Directive EC 944/2013, classification for skin and eye irritation is not warranted.