Butyl cyanoacetate

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:

1976-05-25

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable for reliability but not in detail documented. Study report meets basic scientific principles. Study was conducted prior to GLP and OECD guideline implementation.

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

other: DOT (Transport-Classification) Guideliens

Deviations:

not specified

Principles of method if other than guideline:

The study was performed before GLP- and OECD-testing guidelines were available and in force. The intact and abraded skin of 6 albino rabbits was employed for this study.

GLP compliance:

no

Remarks:

GLP-guidelines not yet in force at date of the study

Species:

rabbit

Strain:

not specified

Type of coverage:

occlusive

Preparation of test site:

abraded

Vehicle:

unchanged (no vehicle)

Controls:

not required

Duration of treatment / exposure:

4 hours

Observation period:

4, 24 and 48 hours on intact and abraded skin

Number of animals:

6 albino rabbits were employed for this study.

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 4, 24 and 48 hour

Score:

0

Max. score:

0

Reversibility:

no data

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 4, 24 and 48 hours

Score:

0

Max. score:

0

Reversibility:

no data

Other effects:

No data available.

Skin reaction	Reading (hours)	Individual scores – rabbit no. & sex
		1	2	3	4	5	6
Erytehma/Eschar	4 24* 48* 72	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0
Total of *                                     0           0           0            0           0         0
Mean values of *                         0.0         0.0        0.0         0.0       0.0       0.0
Oedema	4 24* 48* 72	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0
Total of *		0	0	0	0	0	0
Mean values of *		0.0	0.0	0.0	0.0	0.0	0.0

 

Overall mean of * for Erythema/Eschar: 0.0

Overall mean of * for Oedema:               0.0

 

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The irritation index is 0.0 and therefore, Butyl cyanoacetate will be not classified as skin irritant to the rabbit skin.

Executive summary:

The study was performed 1976, following the DOT (Transport Classification) Guidelines, before GLP- and OECD-testing guidelines were available and in force and amended in year 1991 (Addendum to Lonza Report No. 0434). A couple of substances were tested in one study. The intact and abraded skin of 6 albino rabbits was employed for this study. A series of 6 rabbits was used for testing each substance. The patches consisted of 1.5 inch x 1.5 inch 12 ply gauze squares. The patches were secured to the area by thin bands of adhesive tape (occlusive application). The material to be tested 0.5 mL was introduced beneath the patch. The entire trunks of the animals were then wrapped in clear plastic trunk bands.

The irritation index is 0.0 and therefore, Butyl cyanoacetate will be not classified as skin irritant to the rabbit skin.

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:

1981-06-30

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable for reliability but not in detail documented. Study report meets basic scientific principles. Study was conducted prior to GLP and OECD guideline implementation.

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

other: Code of Federal Regulations, Title 16, Section 1500.42

Deviations:

not specified

Principles of method if other than guideline:

Schleimhautreizwirkung Testung am Kaninchenauge aus: Code of Federal Regulations, Title 16, Section 1500.42

GLP compliance:

no

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 24, 48 and 72 hours after instillation and after 8 days (8d findings are not included in the evaluation of the irritation index). Observation of the eyes was aided by the use of a ophthalmoscops.

Number of animals or in vitro replicates:

6

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 hours

Score:

6

Reversibility:

fully reversible within: after 72 hours

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 48 hours

Score:

5

Reversibility:

fully reversible within: after 72 hours

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 72 hours

Score:

1.6

Reversibility:

fully reversible within: after 72 hours

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24 and 48 hours

Score:

3.3

Reversibility:

fully reversible within: after 72 hours

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 72 hours

Score:

0.8

Reversibility:

fully reversible within: after 72 hours

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 hours

Score:

7.3

Reversibility:

fully reversible within: after 72 hours

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 48 hours

Score:

4

Reversibility:

fully reversible within: after 72 hours

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 72 hours

Score:

3

Reversibility:

fully reversible within: after 72 hours

Other effects:

No corneal damage or iridial inflammation was seen throughout the observation period.
Conjunctival reddening and a slight swelling was noticed. Clear colorless eye defluxion was observed.
All reactions had resolved 72 hours after instillation.

Group mean score at 1h: ---                     Maximum mean score: 17

Group mean score at 24h: 17 Group mean score at 72h > 0

Group mean score at 48h: 12

Group mean score at 72h: 6

Group mean score at 7d: 0

Result: moderate irritant

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 study was performed 1981, following the Code of Federal Regulations, Title 16, Section 1500.42, before GLP- and OECD-testing guidelines were available and in force and amended in year 1993 (Addendum to Lonza Report No. 0435).

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

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

Examination of the eyes were made after 24, 48 and 72 hours after instillation. No corneal damage or iridial inflammation was seen throughout the observation period. Conjunctival reddening and a slight swelling was noticed. Clear colorless eye defluxion was observed. All reactions had resolved 72 hours after instillation.

In conclusion, the test item is not irritating to the rabbit eye.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)