2,2'-phenyliminodiethanol

Endpoint summary

Description of key information

Skin irritation

2,2’-(phenylimino)diethanolwas applied to the skin of two rabbits with an occlusive covering for one minute, 5 minutes, 15 minutes and 20 hours. After the application time, the skin was washed. Animals were observed for 8 days.No irritation was observed after 24 hours and 8 days on the animals exposed for 1, 5, 15 minutes and 20 hours. (BASF SE, 1974).

 

Eye irritation

Two White Vienna rabbits received 50 mg of 2,2’-(phenylimino)diethanol in the conjunctival sac of one eye. The adjacent eye received talcum powder as a control. The animals were scored 1, 24 h and 8 days after application. After 1 h application slight redness, marked edema, slight to marked corneal opacity and corneal release was observed in both animals. After 24 h also slight redness, slight edema and slight corneal opacity were observed in both animals. A foamy discharge was observed in one animal and secretion in the other. 8 days after application slight redness and slight corneal opacity observed in both animals. (BASF SE, 1974).

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:

other: Animal experimental study, predates implementation of GLP and/or development of study guidelines, limitations in design and/or reporting but otherwise adequate for assessment

Principles of method if other than guideline:

According to BASF-internal standard: Two white Vienna rabbits were treated for 1, 5 and 15 minutes and for 20 hours using occlusive conditions. An application site of 2.5 x 2.5 cm was covered with moistened test substance. After the application time, the skin was washed. Animals were observed for 8 days.

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

- Weight at study initiation: female 2.77 kg, male 2.91 kg

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other:

Controls:

other: untreated skin of the same animal

Amount / concentration applied:

80% aqueous test substance preparation.

Duration of treatment / exposure:

1, 5, 15 min, and 20 h

Observation period:

8 days

Number of animals:

2

Details on study design:

Application area: 2.5 x 2.5 cm2
After the application time the skin was washed with 50% Lutrol/water

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No irritation was observed after 24 hours and 8 days on the animals exposed for 1, 5, 15 minutes and 20 hours.

Interpretation of results:

not irritating

Remarks:

Migrated information

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:

other: Animal experimental study, predates implementation of GLP and/or development of study guidelines, limitations in design and/or reporting but otherwise adequate for assessment

Principles of method if other than guideline:

According to BASF-internal standard: Two White Vienna rabbits received 50 mg of the test substance in the conjunctival sac of one eye. The adjacent eye received talcum powder as a control. The animals were scored 1, 24 h and 8 days after application.

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 3.0 and 3.4 kg

Vehicle:

unchanged (no vehicle)

Controls:

other: talcum powder, in the other eye of same animal

Amount / concentration applied:

ca. 50 mg

Duration of treatment / exposure:

Single application to the conjunctival sac of the eye

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE: substance was not removed
SCORING SYSTEM: readings were performed 1 h, 24 h, and 8 d after application

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 h

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 h

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 8 days

Irritant / corrosive response data:

Test substance:
- 1 h after application: Slight redness, marked edema, slight to marked corneal opacity and corneal release was observed in both animals.
- 24 h after application: Slight redness, slight edema, and slight corneal opacity were observed in both animals. A foamy discharge was observed in one animal and secretion in the other.
- 8 days after application: Slight redness and slight corneal opacity observed in both animals.

Control substance (talcum):
- 1 h after application: Slight redness observed in both animals. Slight edema observed in one animal.
- 24 h after application: Slight redness observed in both animals.
- 8 days after application: no effects observed.

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Based on the results after 8 days, slight redness an slight corneal opacity, the test substance has to be classified as irreversible effects on the eye.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Justification for classification or non-classification

Based on the available studies data on skin and eye irritating properties the test item have to be classified and labelled as eye dam. cat. 1 (H318, causes irreversible effect to eye) according to Regulation (EC) No 1272/2008 (CLP).