Registration Dossier

Administrative data

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 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)

Additional information

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).