Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 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)

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).