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
Study period:
1992-10-05 to 1992-11-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
Directive 84/449/EEC
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Rosemead Rabbits, Rosemead, Waltham Abbey, Essex, England
- Age at study initiation: approximately three and a half to four and a half months old
- Weight at study initiation: 2.72 - 3.58 kg
- Housing: in a lagomorph room within a limited-access building
- Diet: free access to food hoppers containing standard pelleted rabbit diet
- Water: free access to tap water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 20 °C
- Humidity: 50 - 58 %
- Air changes: approximately 15 complete air changes per hour without re-circulation
- Photoperiod: a lighting cycle of 12 hours artifical light per day

IN-LIFE DATES: From: 1992-10-05 To:1992-11-06

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 g
Duration of treatment / exposure:
once
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: none

SCORING SYSTEM:
Criteria for assessment to pain response:
1) Reaction of animal to instillation of test material:
- No response: 0 (No initial pain)
- A few blinks only; normal within one or two minutes: 1 ( Practically no initial pain)
- Rabbit blinks and tries to open eye but the reflexes close it: 2 (slight inittal pain)
- Rabbit holds eye shut and puts pressure on lids; may rub eye with paw: 3 (Moderate initial pain)
- Rabbit holds eye shut vigorously; may squeal: 4 (Severe initial pain)
- Rabbit holds eye shut vigorously; may squeal, claw at eye and try to escape: 5 (Very severe initial pain)

2) Criteria for assessment of ocular lesions:
2a) Cornea:
- No opacity: 0
- Scattered or diffuse aeas of opacity, (other than slight dulling of normal lustre) details of iris clearly visible: 1
- Easily discernible translucent areas, details of iris slightly obscured: 2
- Nacreous areas, no details of iris visible, size of pupil barely discernible: 3
- Complete corneal opacity, iris not discernible: 4

2b) Iris:
- Normal: 0
- Markedly deepened folds, congestion, swelling, moderate circumcorneal injection: 1
- No reaction to light, haemorrhage, gross destruction: 2

2c) Conjunctivae:
Redness:
- Vessels normal: 0
- Some vessels definitely injected: 1
- Diffuse, crimson-red, individual vessels not easily discernible: 2
- Diffuse beefy-red: 3

Chemosis:
- No swelling: 0
- Any swelling above normal: 1
- Obvious swelling with partial eversion lids: 2
- Swelling with lids about half-closed: 3
- Swelling with lids more than half-closed: 4

3) Additional criteria for assessment of ocular lesions:
3a) Cornea:
Area of cornea affected by lesion:
- No lesion: 0
- One- quarter or less, but not zero: 1
- Greater than one-quarter, less than one half: 2
- Greater than one-half, less than three-quarters: 3
- Greater than three-quarters, up tp whole area: 4

3b) Conjunctivae:
Discharge:
- No discharge: 0
- Any amount differnt from normal: 1
- Discharge with moistening of the lids and hairs just adjacent to the lids: 2
- Discharge with moistening of the lids and hairs and affecting a considerable area around the eye: 3
- Extensive mucoid discharge: 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
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
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.5
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
A diffuse crimson-red conjunctival appearance or injection of the conjunctival blood vessels was observed in all rabbits during the first 48 hours following instillation of the test item. Very slight or slight chemosis and discharge were observed during the first 24 hours after treatement. Iritis was observed in one rabbit at the 24-hour examination.
The test eye of two rabbits was overtly normal at the 48 hour examination and the third rabbit at the 72 hour examination.
Instillation of the test material caused slight or practically no pain response.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Ditetradecyl peroxydicarbonate was classified as non-irritant to the eye.
Executive summary:

The potential of ditetradecyl peroxydicarbonate to cause damage to the conjunctiva, iris or cornea was assessed in three New Zealand White rabbits, each subjected to a single ocular instillation of 0.1 g of the test material. Ocular reactions were assessed 1, 24, 48 and 72 hours after treatment.A diffuse crimson-red conjunctival appearance or injection of the conjunctival blood vessels (mean score 0.5), very slight or slight chemosis (mean score 0.1) and discharge were observed in all rabbits during the first 48 hours following instillation. Iritis was observed in one rabbit at the 24 hour examination (individual score 0.3). The test eyes of all rabbits were overtly normal at the 72 hour examination. Instillation of the test item caused a very slight initial pain response. Ditetradecyl peroxydicarbonate was classified as non-irritant to the eye.