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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:
December 10-December 19, 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to OECD and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
White powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd. UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.72-3.11 kg
- Fasting period before study: yes
- Housing: suspended metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):17-20 C
- Humidity (%): 48-65%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: December 10, 1998 To:December 18, 1998

Test system

Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL
Observation period (in vivo):
1, 24, 48, 72 hours after treatment
Number of animals or in vitro replicates:
3
Details on study design:
To minimise the pain after treatement 1 drops of proxymetacaine HCL was added added 1 to 2 mins after treatment

SCORING SYSTEM: Svoring based on standard Draize system and classification based on a modified Kay and Calandra scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 hour
Score:
> 13.6 - < 13.8
Reversibility:
not specified
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours
Score:
> 4.6 - < 4.8
Reversibility:
not specified
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 hours
Score:
> 0 - < 0.1
Reversibility:
fully reversible within: 72 hour
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24,48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effect noted
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24,48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24,48 and 72 hours
Score:
0.33
Max. score:
1
Reversibility:
not fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24,48 and 72 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
no coreneal effect were noted. Iridial inflamation was confined to one treatment eye one hour after exposue. moderate conjunctival irritation was noted in all eyes one hours after treatment which regressed to minimal in all animals at 72 hours. All eyes appreared normal after 48 hours.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material produced a mean scoreof 13.7 and was classified as a minimal irriant (class 3 on a 1 - 8 scale) but not classified per the CLP regulation.
Executive summary:

The test material did not meet the criteria for classification as an irritant according to CLP regulations.