Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Not skin irritating

Nor eye irritating

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:
January from 10th to 13th, 2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
other: intact skin
Controls:
yes, concurrent no treatment
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4-hour
Observation period:
72 hours
Number of animals:
Three rabbits
Details on study design:
OBSERVATION TIME POINTS
Skin reactions were recorded 1, 24, 48 and 72 hours after administration.
Irritation parameter:
erythema score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
< 2.3
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
< 2.3
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Primary Initation Index: 0
Yellow staining of the test site was recorded at the 1 and 24-hour observations which did not affect the evaluation of skin respotrses.

Individual skin reactions following 4 -hour exposure period

Animal no. Reaction Observation at Mean 24/48/72 hrs
1 hr 24 hrs 48 hrs 72 hrs
41 Male Erythema 0 0 0 0 0
Oecdma 0 0 0 0 0
40 Male Erythema 0 0 0 0 0
Oecdma 0 0 0 0 0
43 Male Erythema 0 0 0 0 0
Oecdma 0 0 0 0 0
Interpretation of results:
other: not classified, according to the CLP Regulation (EC 1272/2008)
Conclusions:
Not skin irritating
Executive summary:

A study was performed to assess the irritation of the test material to the skin of the New Zealand White rabbit (SPL Standard Test Method 540.05). The method followed OECD guideline 404 and method B4 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

A single, 4-hour semi-occluded application (500 mg) 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.

No erythema or oedema was noted, thus scores of skin reactions in all animals were 0. Yellow staining of the test site was recorded at the 1 and 24-hour observations which did not affect the evaluation of skin responses.

Conclusion

Mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions, thus the test item is not a skin irritant.

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:
January from 18th to 25th, 2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rat
Strain:
New Zealand White
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml (67.3 mg) of the test material was administered to the non irrigated eye.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
Three rabbits
Irritation parameter:
cornea opacity score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
< 1
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
< 1
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal:
Time point:
24/48/72 h
Score:
< 2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
< 2
Reversibility:
fully reversible within: 48 hrs
Irritant / corrosive response data:
Maximum Group Mean Score was 4.1
Classification: mild irritant (class 4 on a 1-8 SCALE).
The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations Commission Directive 93/21/EEC. No symbol and risk phrase are required.

lndividual scores for ocular irritation

Animal no. Reaction Observation at Mean 24/48/72 hrs
1 hr 24 hrs 48 hrs 72 hrs
146 male Corneal opacity 0 0 0 0 0.00
Iris 0 0 0 0 0.00
Conjunctival redness 0 0 0 0 0.00
Conjunctival chemosis 0 0 0 0 0.00
151 male Corneal opacity 0 0 0 0 0.00
Iris 0 0 0 0 0.00
Conjunctival redness 1 1 1 0 0.67
Conjunctival chemosis 1 1 1 0 0.33
153 male Corneal opacity 0 0 0 0 0.00
Iris 0 0 0 0 0.00
Conjunctival redness 1 0 0 0 0.00
Conjunctival chemosis 0 0 0 0 0.00
Interpretation of results:
other: not classified, according to the CLP Regulation (EC 1272/2008)
Conclusions:
Not eye irritating.
Executive summary:

A study was performed to assess the irritation of the test material to the eye of the New Zealand White rabbit (SPL Standard Test Method 560.06). The method followed OECD guideline 405 and method B5 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC). A single application of 0.1 ml (67.3 mg) of the test material was administered to the non irrigated eye of three rabbits. Ocular reactions were observed at 1, 24, 48 and 72 hours after administration.

The Maximum Group Mean Score was 4.1 and the related classification was as mild irritant (class 4 on a 1 -8 SCALE).

Where present, reactions were slight and fully reversible within 72 hours.

Conclusion

The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and oedema, in all of the three tested animals.

Therefore, the substance is not an eye irritant.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

SKIN IRRITATION

A study was performed to assess the irritation of the test material to the skin of the New Zealand White rabbit (SPL Standard Test Method 540.05). The method followed OECD guideline 404 and EU method B4. A single, 4 -hour semi-occluded application (500 mg) of the test material was administered to the intact skin of three rabbits. Observations of skin reactions were done at 1, 24, 48 and 72 hours after administration. Animals were assessed for erythema and oedema and scores were all 0. Yellow staining of the test site was recorded at the 1 and 24-hour observations which did not affect the evaluation of skin responses.

EYE IRRITATION

A study was performed to assess the irritation of the test material to the eye of the New Zealand White rabbit (SPL Standard Test Method 560.06). The method followed OECD guideline 405 and the method B.5. A single application of 0.1 ml (67.3 mg) of the test material was administered to the non irrigated eye of three rabbits. Observations of ocular reactions were done at 1, 24, 48 and 72 hours after administration. All effects were slight and fully reversible within 72 hours.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), 3.2 Skin corrosion/irritation section, skin irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.

Mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions, thus the test item does not meet the criteria to be classified as irritating, according to the CLP Regulation (EC 1272/2008).

According to the CLP Regulation (EC 1272/2008), serious eye damage means the production of tissue damage in the eye upon application of a test substance, which is not fully reversible after 21 days from application.

The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and oedema, in all of the three tested animals. All the reactions resulted to be fully reversible withing 72 hours. Therefore, the substance does not meet the criteria to be classified as eye irritating, according to the CLP Regulation (EC 1272/2008).