Registration Dossier

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: 1a Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name: Ethylenediamine, propoxylated mw 360 (NLP)
Color: brownish
Purity: not reported

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS: rabbit
- Strain: himalayan
- Sex: males
- Source: Leuschner & Co., Löhndorf, Germany
- Age: approx. 5 months
- Weight at study initiation: 2200 - 2400 g
- Number of animals: 3
- Controls: untreated eye served as control

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
undiluted
Amount applied: 0.1 ml
Duration of treatment / exposure:
unspecified
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
ADMINISTRATION/EXPOSURE
- Preparation of test substance: Undiluted
- Amount of substance instilled: 0.1 ml
- Vehicle: None
- Postexposure period: 7 days

EXAMINATIONS
- Ophthalmoscopic examination: Yes
- Scoring system: Draize
- Observation period: 1, 24, 48, 72 hours and 4, 7 days post-instillation
- 24 hours and 7 days after administration the eyes were treated additionally with fluorescein and examined.
- Tool used to assess score: Standard ophthalmoscope

Comment: not rinsed

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72 hr average
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 DAYS
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, 72 hr average
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48, 72 hr average
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, 72 hr average
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: iris (severely) reduced in size
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, 72 hr average
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: iris (severely) reduced in size
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48, 72 hr average
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: iris (severely) reduced in size
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 hr average
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 6 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 hr average
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, 72 hr average
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 18 hrs
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 hr average
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 hr average
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72 hr average
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hrs
Irritant / corrosive response data:
AVERAGE SCORE (24+48+72 hour)
- Cornea: 1
- Iris: 1
- Conjuntivae (Redness): 0.6
- Conjuntivae (Chemosis): 0.6

DESCRIPTION OF LESIONS:
Cornea1 opacity (grade 1) was observed in all three animals at the examination time points one hour to 5 days after instillation, in animal no. 3 until 6 days after instillation. All animals showed an irritation of the iris (grade 2) one hour after instillation, and an irritation (grade 1) 24 to 5 days in all animals, in animal no. 3 up to 6 days after instillation. Conjunctival redness of grade 1 was observed in all animals 1 to 24 hours after instillation, in animal no. 1 up to 5 days after instillation. Conjunctival chemosis (grade 1) was observed in all animals 1 to 24 hours after instillation, in animal no. 1 up to 72 hours after instillation. The fluorescein test performed after 24 hours revealed corneal staining in animal nos. 1 and 3 (1/2 of the corneal surface) and in animal no. 2 (1/4 of the corneal surface).

REVERSIBILITY: day 7 all scores at 0
Other effects:
There were no systemic intolerance reactions.

Any other information on results incl. tables

AVERAGE SCORE (24+48+72 hour) - Cornea: 1 - Iris: 1 - Conjuntivae (Redness): 0.6 - Conjuntivae (Chemosis): 0.6 DESCRIPTION OF LESIONS: Cornea1 opacity (grade 1) was observed in all three animals at the examination time points one hour to 5 days after instillation, in animal no. 3 until 6 days after instillation. All animals showed an irritation of the iris (grade 2) one hour after instillation, and an irritation (grade 1) 24 to 5 days in all animals, in animal no. 3 up to 6 days after instillation. Conjunctival redness of grade 1 was observed in all animals 1 to 24 hours after instillation, in animal no. 1 up to 5 days after instillation. Conjunctival chemosis (grade 1) was observed in all animals 1 to 24 hours after instillation, in animal no. 1 up to 72 hours after instillation. The fluorescein test performed after 24 hours revealed corneal staining in animal nos. 1 and 3 (1/2 of the corneal surface) and in animal no. 2 (1/4 of the corneal surface). REVERSIBILITY: day 7 all scores at 0

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the present test conditions, ethylenediamine, propoxylated was classified as irritating to eyes.