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Administrative data

Description of key information

Skin irritation: not irritating
Eye irritation: slightly irritating

Key value for chemical safety assessment

Skin irritation / corrosion

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study in full compliance with OECD guideline.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
other: Crl:KBL(NZW)BR
Details on test animals or tissues and environmental conditions:
according to guideline
sex of the test animals: female
Vehicle:
unchanged (no vehicle)
Controls:
other: The other eye, which remained untreated, served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 100%
Duration of treatment / exposure:
The lids were gently held together for about one second in order to prevent loss of the test compound. The eye was rinsed approximately 24 hours following instillation.
Observation period (in vivo):
1, 24, 48, 72 hours post application. If eye irritations were observed, animals were monitored usually on day 7, 14 and 21 after application until the changes had completely subsided.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 24 hours after instillation the eye was rinsed

SCORING SYSTEM: Draize, any serious lesions or toxic effects other than ocular lesions were also recorded and fully described.

EXPOSURE PROCEDURE:
For reasons of animal welfare a stepwise approach was done. Into the conjunctival sac of one animal t0.1 ml test substance was placed. As one hour after treatment a severe irritation was not observed, two further rabbits were treated as before.
Irritation parameter:
cornea opacity score
Basis:
animal: 1, 2, 3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: 1, 2, 3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 1 - <= 3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: mean score after 72 hours: 2
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 1 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: mean score after 72 hours: 1.7
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: mean score after 72 hours: 2
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 0 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: mean score after 72 hours: 1
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
4
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: mean score after 72 hours: 0.7
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
4
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: mean score after 72 hours: 0.7
Other effects:
There were no systemic intolerance reactions.
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
As a result of 2 of the 3 animals tested having a conjunctival redness score of 2, reversible within 7 days, this material should be classified for eye irritation as a category 2.
Executive summary:

An acute eye irritation/corrosion test (OECD 405) was performed with NLP # 10 (ortho-Toluene diamine, propoxylated).


The substance should be classified for eye irritation according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Two studies are available for Skin irritation, one (in-vivo) performed with 3 rabbits and according to or similar to OECD 404 and the other in-vitro study performed on human skin according to OECD 431. The results of the study indicated Diaminotoluene, propoxylated not to be an irritant or corrosive

The findings do not warrant classification according to the EU scheme.

The study available on eye irritation was performed according to OECD 405 with 3 rabbits and Diaminotoluene, propoxylated was classified as slightly irritating.

Justification for classification or non-classification

The findings in the available study in skin irritation do not warrant classification according to the EU criteria (DSD and CLP).


The substance should be classified for eye irritation according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.