Phthalimide

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Principles of method if other than guideline:

500 mg of phthalimide moistened was applied to the skin (inside ear) of two rabbits for 24 hours. Animals were observed for 7 days

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 3-4 kg
- Housing: the animals were housed individually

Type of coverage:

semiocclusive

Preparation of test site:

other: no treatment, inside ear

Vehicle:

water

Controls:

not required

Amount / concentration applied:

amount: 500 mg

Duration of treatment / exposure:

24 hour(s)

Observation period:

7 days

Number of animals:

2

Details on study design:

TEST SITE
Fixation of the test substance was performed using adhesive bandage on the ear of the rabbit

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after the exposure the test substance was washed away with water and soap/vegetable oil
- Time after start of exposure: 24 hours

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 0, 24, 48 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 0, 24, 48 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 0, 24, 48 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 0,24, 48 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

No irritation was observed at any time point.

Other effects:

no data

Interpretation of results:

not irritating

Executive summary:

Thyssen/Bayer AG (1979):

In a primary dermal irritation study, the skin irritation/corrosion potential of phthalimide was tested. 500 mg/animal of the test substance was applied to the inside of rabbit ear of 2 animals, for 24 hours and animals were observed for 7 days. Phathalimide resulted to be not irritating, as no edema and no erythema were seen at any time point.

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

The eye irritation potential of phthalimide was evaluated by placing 50 mg of test substance in conjunctival sac of one male and one female white New Zealand rabbit. Animals were observed at 0, 24 hours, 2, 3 and 7 days.

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

white New Zealand rabbits, weight 3 to 4 kg

Vehicle:

water

Controls:

not required

Amount / concentration applied:

amount: 50 mg

Duration of treatment / exposure:

single eye instillation

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

2

Details on study design:

Compound was placed in the conjunctival sac of one male and one female white New Zealand rabbit. The eyes were not washed and animals were observed at 0, 24 hours, 2, 3 and 7 days.

SCORE SYSTEM: Draize

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 0, 24 h, 48 h, 7 d

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 0, 24 h, 48 h, 7 d

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 0, 24 h, 48 h, 7 d

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 0, 24 h, 48 h, 7 d

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 0, 24 h, 48 h, 7 d

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 0, 24 h, 48 h, 7 d

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 0, 24 h, 48 h, 7 d

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 0, 24 h, 48 h, 7 d

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

No irritation (score =0) was observed at any timepoint

Other effects:

no data

Interpretation of results:

not irritating

Executive summary:

Thyssen/Bayer AG (1979):

In an acute eye irritation study, 50 mg of phthalimide (purity not stated) was placed in the conjunctival sac of two rabbits. Animals were observed for 7 days. Irritation was scored according to the method of Draize. No eye irritation was observed at any time point.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)