Registration Dossier

Administrative data

Description of key information

No experimental data are available for respiratory irritation

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: A study summary was made available by ECHA under Article 25, Para 3., of EC Regulation 1907/2006
Qualifier:
according to
Guideline:
other: OECD Guideline 404 (1981); EEC Directive 84/449 (1984) Annex V-Method B4, EPA No.798 4470 (1990), MAFF No.4200 (1985)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
other: Sterile codex liquid paraffin
Amount / concentration applied:

46 mg

Duration of treatment / exposure:
4h
Observation period:
Presumed to be 72 hrs
Number of animals:
6
Irritation parameter:
erythema score
Basis:
mean
Score:
0.3
Max. score:
2
Reversibility:
fully reversible
Remarks:
within 3 days
Remarks on result:
other: Maximum duration 48h; Maximum value at end of observation period 0
Irritation parameter:
edema score
Basis:
mean
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks:
within 3 days
Remarks on result:
other: Maximum duration 0 days; Maximum value at end of observation period 0.
Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is slightly irritating to the skin and is not classified according to EU CLP criteria.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (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: A study summary was made available by ECHA under Article 25, Para 3., of EC Regulation 1907/2006
Qualifier:
according to
Guideline:
other: OECD Guideline 405 (1987); EEC Directive 84/449 (1984) Annex V-Method B5, EPA No.798 4500 (1990), MAFF No.4200 (1985)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Amount / concentration applied:
20 mg
Number of animals or in vitro replicates:
6
Irritation parameter:
conjunctivae score
Basis:
mean
Score:
0.56
Max. score:
2
Reversibility:
fully reversible within: 7d
Remarks on result:
other: Maximum duration72 h; Maximum value at end of observation period 0
Irritation parameter:
chemosis score
Basis:
mean
Score:
0.22
Max. score:
2
Reversibility:
fully reversible within: 7d
Remarks on result:
other: Maximum duration 24h; Maximum value at end of observation period 0.
Irritation parameter:
cornea opacity score
Basis:
mean
Score:
0.06
Max. score:
1
Reversibility:
fully reversible within: 7d
Remarks on result:
other: Maximum duration 24 h: Maximum value at end of observation period 0.
Irritation parameter:
iris score
Basis:
mean
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 7d
Remarks on result:
other: Maximum duration 24 h: Maximum value at end of observation period 0.
Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Slight or occasionally moderate transient corneal opacity and iritis were observed amongst the animals during the first 24h after instillation of the test material. Slight or occasionally moderate conjunctival redness accompanied these changes for up to 72 hrs. All of these changes were fully reversible within 7 days. Although eye irritation scores are not available for individual animals, it is considered that the observed effects did not meet the EU CLP criteria for classification as ‘irritating to the eye’.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In the key acute skin irritancy study (Pharmakon Europe, 1993), 0.46 mg of the test material was applied under semi-occlusive dressings to the skin of six New Zealand White rabbits for 4 hours, followed by a 72 -hour observation period. Reactions at the application site were confined to very slight or occasional well-defined erythema amongst the animals. There was no oedema observed. The low irritancy of the material was supported in a more recent study (Safepharm Laboratories Ltd,. 1998), in which similar administration of 0.5 g of the test substance to three New Zealand White rabbits elicited no irritant response at any of the application sites.

In the key in vivo eye irritation study (Pharmakon Europe, 1993), instillation of 20 mg of the test substance to a single eye of six rabbits, followed by a 7-day observation period, elicited slight or occasional moderate transient corneal opacity and iritis amongst the animals during the first 24 hrs.. Slight or occasional moderate conjunctival redness accompanied these changes for up to 72 hrs. All of these changes were fully reversible within 7 days of instillation of the test substance. In a similar more recent study (Safepharm Laboratories Ltd., 1998), irritation responses, following instillation of 41mg of the substance to a single eye of three rabbits, were limited to transient conjunctival redness and chemosis for up to 48 hours.

 


Justification for selection of skin irritation / corrosion endpoint:
There are two in vivo skin irritation studies available (Pharmakon Europe 1993 and Safepharm Laboratories 1998). Although individual animal scores are not available for the older study, the test shows slight erythematous changes to the skin, which are not observed in the more recent study.

Justification for selection of eye irritation endpoint:
There are two in vivo eye irritation studies available (Pharmakon Europe 1993 and Safepharm Laboratories 1998). Although individual animal scores are not available for the older study, the test shows changes to the cornea and iris which are not observed in the more recent study..

Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

The available animal test data are reliable and suitable for classification purposes under regulation 1272/2008. The mean scores for skin or eye irritation responses did not meet the EU CLP criteria for classified of the substance as irritant.