5'-chloro-2'-methoxyacetoacetanilide

Endpoint summary

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:

1989-11-07 to 1989-11-10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was conducted according to EG-Guideline B.4. 84/449/EWG, OECD 404 and under GLP.

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: NaCL solution

Controls:

no

Duration of treatment / exposure:

4 hours

Observation period:

after 30-60 min, 24, 48 and 72 hours

Number of animals:

3 animals

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 30-60 min till 3 days

Score:

0

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 30-60 min till 3 days

Score:

0

Other effects:

No.

Female rabbits:

Erythema, overall mean: 0.0

Oedema, overall mean: 0.0

The means have been calculated using the day 1,2 & 3 values.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Due to the test results, the test item is not irritating to the rabbit skin.

Executive summary:

The study was performed according to EG-Guideline B.4. 84/449/EWG, OECD 404 and under GLP.

Due to the test results, the test item will not be classified as irritating to the rabbit skin and does not require labelling according to

Regulation 1272/2008/EEC (CLP) and according to Directive 67/548/EEC (DSD).

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:

1989-11-28 to 1989-12-01

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study documented and performed according to GLP standards and in compliance with Directive 84/449/EC, Part B, Method B5 and OECD Guideline 405.

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

not applicable

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not applicable

Principles of method if other than guideline:

Not applicable.

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

Examination of the eyes was made after 1, 24, 48 and 72 hours after instillation. Observation of the eyes was aided by the use of
a handheld torch.

Number of animals or in vitro replicates:

3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1, 24 , 48, 72 hours and 7 day

Score:

0

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1, 24 , 48, 72 hours and 7 day

Score:

0

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1 hour

Score:

8

Max. score:

8

Reversibility:

fully reversible within: 72h

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 hours

Score:

5

Max. score:

6

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 48 hours

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

0

Other effects:

No corneal damage or iridial inflammation was seen throughout the observation period.
Conjunctival inflammation was evident in all three animals after one hour till 48 hours.
Conjunctival reddening and a slight swelling was noticed. Clear colorless eye defluxion was observed.
All reactions had resolved 72 hours after instillation.

Animal No.	1	2	3
3 hours/days	1  24  48  72  7	1  24  48  72  7	1  24  48  72  7
Cornea
E = Degree	0	0	0
F = Area	0	0	0
(F x E) x 5	0	0	0
D = Iris	0	0	0
D x 5	0	0	0
Conjunctiva
A = Redness	2   1   1   0	2   2   1   0	2   2   1   0
B = Chemosis	1   0   0   0	1   1   0   0	1   1   0   0
C = Discharge	1 0 0 0	1 0 0 0	1 0 0 0
(A + B+ C) x 2	8  2   2   0	8   6   2   0	8   6   2   0
Total	8  2  2   0	8   6   2   0	8   6   2   0

Group mean score at 1h: 8                     Maximum mean score: 8

Group mean score at 24h: 5

Group mean score at 48h: 2

Group mean score at 72h: 0

Group mean score at 7d:----

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item is not irritating to the rabbit eye.

Executive summary:

The experimental procedure complied with EEC Methods for determination of toxicity Directive 84/449/EEC, Method B5 and OECD Guideline for testing of chemicals, 405. The study was documented and performed according to GLP standards.

Three New Zealand White strain albino rabbits were chosen in this test.

The test substance was administered unchanged in the conjunctival sac of the left eye.

Examination of the eyes were made after 1, 24, 48 and 72 hours after instillation.

No corneal damage or iridial inflammation was seen throughout the observation period. Conjunctival inflammation was evident in all three animals after one hour till 48 hours. All reactions had resolved 72 hours after instillation.

In conclusion, the test item is not irritating to the rabbit eye and therefore has not been classified as irritating and does not require labelling according to Regulation 1272/2008/EEC (CLP) and according to Directive 67/548/EEC (DSD).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
Study was conducted according to EG-Guideline B.4. 84/449/EWG, OECD 404 and under GLP.

Justification for selection of eye irritation endpoint:
Study documented and performed according to GLP standards and in compliance with Directive 84/449/EC, Part B, Method B5 and
OECD Guideline 405.

Justification for classification or non-classification

Based on the irritation/corrosion data available, the substance is not classified as irritating and does not require labelling according to Regulation 1272/2008/EEC (CLP) and according to Directive 67/548/EEC (DSD).