Diallyl isophthalate

Endpoint summary

Description of key information

Studies used were read across from DAP a closely related structural analogue. Full justification given in Attachment. Indicate that DAIP is not irritating to skin or eyes.

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:

supporting study

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Justification for type of information:

ANALOGUE APPROACH JUSTIFICATION
Please refer to attached document.

Qualifier:

according to guideline

Guideline:

other: 16 CFR 1500.41

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

not specified

Species:

rabbit

Type of coverage:

semiocclusive

Preparation of test site:

abraded

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Duration of treatment / exposure:

72 hours

Observation period:

72h

Number of animals:

No data

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

72 h

Score:

2.29

Reversibility:

not specified

Remarks on result:

probability of mild irritation

Interpretation of results:

Category 3 (mild irritant) based on GHS criteria

Conclusions:

Study is interpretable but conclusions should be amended in context of OECD guideline 404.

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

Study period:

Date of Study Report: August 9, 1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given : Comparable to quidelines/standards

Justification for type of information:

ANALOGUE APPROACH JUSTIFICATION
Please refer to attached document.

Qualifier:

according to guideline

Guideline:

other: 16 CFR 1500.42

Deviations:

yes

Remarks:

: The test procedure was modified as follows: In Group I, Six rabbits; eyes unwashed following the instillation of the test material. In Group II, Three rabbits; eyes washed 4 seconds following instillation of the test material.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

: Washout after 4s, no information on a preliminary in vitro study

GLP compliance:

no

Species:

rabbit

Strain:

other: Albino

Details on test animals or tissues and environmental conditions:

The acute eye irritation test was determined on 9 young adult albino rabbits, selected from healthy, acclimated animals.

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml or 0.1g

Duration of treatment / exposure:

Single application

Observation period (in vivo):

All eyes were observed and ocular reaction recorded at 24, 48, and 72 hours after instillation of the test material. They were observed again after 7 days.

Number of animals or in vitro replicates:

Group I: 6 rabbits with eyes unwashed following the instillation of the test material
Group II: 3 rabbits with eyes washed for 4 seconds following instillation of the tests material

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any or all eyes may be washed with sodium chloride solution U.S.P. or equivalent .
- Time after start of exposure: after the 24-hour reading.

SCORING SYSTEM:

TOOL USED TO ASSESS SCORE: Reading of reactions is facilitated by use of a binocular loupe, hand slit-lamp, or other expert means. After the recording of observations at 24 hours, any or all eyes may be further examined after applying fluorescein.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 48h

Remarks on result:

probability of weak irritation

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48h

Remarks on result:

probability of weak irritation

Irritant / corrosive response data:

Group I : Conjunctival effects were observed in four animals. These effects cleared during the 72-hour observation period.
Group II : Conjonctival effects were observed in all three animals. These effects cleared during the 48-hour observation period.

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

On the basis of the data presented herein the following is concluded for the test material, FMC Corporation; D.A.P. (1 Qt. Net Wt.); C-8013-3:
Group I and II: It is a mild transient irritant to the rabbit eye when not followed by or followed by a washout 4 -seconds after instillation of the test material.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Although the studies used for assessing the potential of DAP to cause irritation of both eye and skin are not reliable without restrictions, they provide relevant and consistent data indicating that DAP is only slightly irritant to both skin and eye. In the interest of both sound science and animal welfare, further in vivo testing should not be considered necessary.

Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

Based on the data presented here, DAP and threfore DAIP is not to be classified as irritant to either skin or eye. In extrapolation to humans, it can be safely concluded that DAP is not irritant to the human skin or eye. In many cases the albino rabbit is more sensitive than humans to ocular irritants or corrosives. There are also no known reports of irritation of human skin or eye after accidental exposure, which is consistent with the animal studies and provides further indications that classification for skin or eye irritation is not needed.