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Toxicological information

Eye irritation

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Administrative data

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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tercarol 5903, NLP # 10 (orthp-Toluene diamine, propoxylated)
- Lot/batch No.: VD 04080734
- Molecular weight: Mn = 340 g/mole
- Physical state: viscous fluid
- Storage condition of test material: room temperature
- Expiration date of the lot/batch: 2009-04-30

Test animals / tissue source

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

Test system

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.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 1, 2, 3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: 1, 2, 3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
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:
other: 24, 48 and 72 hours
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:
other: 24, 48 and 72 hours
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:
other: 24, 48 and 72 hours
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:
other: 24, 48 and 72 hours
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:
other: 24, 48 and 72 hours
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.

Applicant's summary and conclusion

Executive summary:

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

Classification for eye irritation is not applicable according to EU Directive 67/548/EEC. 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.