Registration Dossier

Administrative data

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: Assessed after consultation with the relevant Authority. Data migrated from NONS files provided by Authority contain insufficient information.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Report Date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes
Remarks:
PHARMACO-LSR LTD. EYE, SUFFOLK IP23 7PX

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): BTN/A
- Analytical purity: no data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
24, 48, 72 hours to 15 days
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48, 72 hours
Score:
1.3
Reversibility:
fully reversible within: 15 days
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 hours
Score:
2.5
Reversibility:
not specified
Remarks on result:
other: Due to the severity of the response to the test material, animal #2 was humanely killed after 48 hours (i.e. on day 3)
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48, 72 hours
Score:
2
Reversibility:
fully reversible within: 15 days
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal: #1, 2, 3 (highest value)
Time point:
other: no data
Score:
3
Reversibility:
fully reversible within: 15 days
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48, 72 hours
Score:
0.7
Reversibility:
fully reversible within: 15 days
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 hours
Score:
2
Reversibility:
not specified
Remarks on result:
other: Due to the severity of the response to the test material, animal #2 was humanely killed after 48 hours (i.e. on day 3)
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48, 72 hours
Score:
0.3
Reversibility:
fully reversible within: 15 days
Irritation parameter:
chemosis score
Basis:
animal: #1, 2, 3 (highest value)
Time point:
other: no data
Score:
2
Reversibility:
fully reversible within: 15 days
Remarks on result:
other: Max. duration: 72 hours; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48, 72 hours
Score:
0.3
Reversibility:
fully reversible within: 15 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 hours
Score:
1
Reversibility:
not specified
Remarks on result:
other: Due to the severity of the response to the test material, animal #2 was humanely killed after 48 hours (i.e. on day 3)
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48, 72 hours
Score:
0
Reversibility:
other: no effects
Irritation parameter:
cornea opacity score
Basis:
animal: #1, 2, 3 (highest value)
Time point:
other: no data
Score:
1
Reversibility:
fully reversible within: 15 days
Remarks on result:
other: Max. duration: 48 hours; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48, 72 hours
Score:
0.3
Reversibility:
fully reversible within: 15 days
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 hours
Score:
1
Reversibility:
not specified
Remarks on result:
other: Due to the severity of the response to the test material, animal #2 was humanely killed after 48 hours (i.e. on day 3)
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48, 72 hours
Score:
0
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
animal: #1, 2, 3 (highest value)
Time point:
other: no data
Score:
1
Reversibility:
fully reversible within: 15 days
Remarks on result:
other: Max. duration: 48 hours; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 15 days
Other effects:
Other observed effects in the eye of animal #2 were slight discharge with mucus, and two small areas of haemorrhage.

Effects on the two surviving animals were slight injection of the conjunctival blood vessels until the 24 hour examination and very slight and/or slight discharge until the 48 hour or 72 hour observations.

These effects had reversed by the Day 15 observation.

Conjunctival redness, chemosis and discharge (scores 1, 1 and 2 respectively in each animal) were seen at the one hour observation time. Instillation of the test material caused practically no initial pain response.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DSD: R36
CLP: eye irritation category 2