[No public or meaningful name is available]

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

other: method described in Official newspaper of FrenchRepublic (1982-02-22)

GLP compliance:

yes

Species:

rabbit

Type of coverage:

semiocclusive

Vehicle:

water

Duration of treatment / exposure:

24 h

Number of animals:

6

Irritation parameter:

erythema score

Basis:

mean

Score:

0

Max. score:

1

Remarks on result:

other: Max. duration: 72 d; Max. value at end of observation period: 0

Irritation parameter:

edema score

Basis:

mean

Score:

0

Max. score:

1

Remarks on result:

other: Max. duration: 72 d; Max. value at end of observation period: 0

Irritant / corrosive response data:

Reversibility of any observed effect: Changes fully reversible within 3 days

Interpretation of results:

other: not classified

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

other: clinical quotation

Deviations:

no

Principles of method if other than guideline:

The clinical quotation is made 30 minutes after the patch removal and takes in account the erythema, the papules, the vesicles and the blisters. According to their intensity, the quotation is spread out from 0 to 3. The total sum of the scores, divided by the number of volunteers, defines the mean irritation index (M.I.I.), which allows to classify arbitrarily the test item into “non irritant, slightly irritant, moderately irritant, very irritant and severely irritant"

GLP compliance:

no

Species:

human

Details on test animals or test system and environmental conditions:

Normal skin without any dermatological lesion on the experiental area

Type of coverage:

semiocclusive

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

Single application of 5 mg of the studied test item pure on the external face of the arm

Duration of treatment / exposure:

48h in contact with the skin, with the help of a semi-occlusive patch

Observation period:

Clinical quotation made 30 minutes after the patch removal

Number of animals:

20 volunteers of the female or male sex from 18 to 65 years old

Irritation / corrosion parameter:

other: other: mean irritation index (M.I.I)

Value:

0

Remarks on result:

other:

Remarks:

Basis: other: human. Time point: 48 hours. Reversibility: no data. (migrated information)

Other effects / acceptance of results:

The mean irritation index (MII) of the test item is 0. The test item can be considered as non-irritant

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Qualifier:

according to guideline

Guideline:

other: Methode officicelle pour l'evaluation de l'irritation oculaire

Version / remarks:

Method described in J.O. of 10/07/92

Principles of method if other than guideline:

Methode officicelle pour l'evaluation de l'irritation oculaire

GLP compliance:

no

Species:

rabbit

Strain:

other: Albinos

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

72h

Observation period (in vivo):

1h, 24h, 48h and 72h

Number of animals or in vitro replicates:

3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Irritant / corrosive response data:

Comments:This test was realized by a laboratory which is not certified by BPL.
The observation of ocular lesions was not pursued beyond 72 hours after the product application. At
this time, it remained an eryhtema of conjonctiva level 1 in one rabbit.
Given the weak irritation, there is no need to think that this substance could cause an irreversible effect.
It is not appeared a justification to make this test again.

Interpretation of results:

GHS criteria not met

Conclusions:

The contact of the product to test with the Albino rabbit's ocular mucous membrane had caused only
one significant and usual reaction of conjonctiva without no particular consequence. Considering the
small rate of Index of Ocular Maximum Irritation (7.0), the expert concludes that, according to official
numerical classification, the product is completely lacking in any irritant effect for the ocular mucous
membrane

Executive summary:

The contact of the product to test with the Albino rabbit's ocular mucous membrane had caused only

one significant and usual reaction of conjonctiva without no particular consequence. Considering the

small rate of Index of Ocular Maximum Irritation (7.0), the expert concludes that, according to official

numerical classification, the product is completely lacking in any irritant effect for the ocular mucous

membrane

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

other justification

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)