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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
Study period:
14 August 2012 - 07 September 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
April 2002
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
May 2008
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
August 1998
Deviations:
no
Qualifier:
according to
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Eye Irritation (2-1-5), 12 Nohsan No. 8147, Agricultural Production Bureau, November 24, 2000
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): BMI (1,1’-(methylenedi-p-phenylene)bismaleimide)
- Substance type: Organic
- Physical state: Light yellow or light brown powder
- Storage condition of test material: Room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 31 or 39 weeks
- Weight at study initiation: 3.69 to 4.46 kg
- Housing: Each animal was housed individually in a plastic cage with perforated floors
- Diet (e.g. ad libitum): standard laboratory rabbit diet per day
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 11 or 17 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16- 20
- Humidity (%): 40 to 70
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light

Test system

Vehicle:
not specified
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL


Duration of treatment / exposure:
After instillation of the test substance the eyelids of each animal were gently held together for one second before releasing
Observation period (in vivo):
1, 24,48, 72 and 8 days after instillation
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Eyes were flushed with saline for animal #1 24 hours after instillation, Eyes were flushed with saline for animal #2 24 hours and 48 hours after instillation. Eyes were not flushed for animal #3

SCORING SYSTEM: Kay and Calandra and EC (Regulation 1272/2008) and GHS classification



Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
Animal #1;#2;#3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: n/a
Remarks on result:
other: The scores are calculated at approximately 24, 48 and 72 hours after administration, separately for each animal
Irritation parameter:
iris score
Basis:
mean
Remarks:
Animal #1;#2;#3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: n/a
Remarks on result:
other: The scores are calculated at approximately 24, 48 and 72 hours after administration, separately for each animal
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: The scores are calculated at approximately 24, 48 and 72 hours after administration, separately for each animal
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: The scores are calculated at approximately 24, 48 and 72 hours after administration, separately for each animal
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: The scores are calculated at approximately 24, 48 and 72 hours after administration, separately for each animal
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: The scores are calculated at approximately 24, 48 and 72 hours after administration, separately for each animal
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: The scores are calculated at approximately 24, 48 and 72 hours after administration, separately for each animal
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: n/a
Remarks on result:
other: The scores are calculated at approximately 24, 48 and 72 hours after administration, separately for each animal

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
An in vivo eye irritation test was performed in new zealand white rabbits. Based on the results, BMI does not have to be classified for eye irritation or serious eye damage according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).
Executive summary:

An in vivo eye irritation test was performed in new zealand white rabbits according to internationally accepted guidelines and in accordance with GLP principles. Following a instillation dose of 0.1 mL,

slight chemosis, slight to moderate discharge, and injection of the conjunctival blood vessels were noted in 1 or more animals, all clinical signs were reversed to normal within 8 days in all test animals.

Based on the results, BMI does not have to be classified for eye irritation or serious eye damage according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).