Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-dithiodi(benzoic acid)
EC Number:
204-352-8
EC Name:
2,2'-dithiodi(benzoic acid)
Cas Number:
119-80-2
Molecular formula:
C14H10O4S2
IUPAC Name:
2-[(2-carboxyphenyl)disulfanyl]benzoic acid
Test material form:
other: Solid
Details on test material:
The test material had a purity of 75.7%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Conventional Animal breeding Unit
- Age at study initiation: Young adult
- Weight at study initiation: 3609-4330g
- Housing: individual aluminium sheet cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-19
- Humidity (%): 40-70
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: other eye of treated animals
Amount / concentration applied:
Approximately 100mg per eye
Duration of treatment / exposure:
Not applicable
Observation period (in vivo):
Up to 7 days
Number of animals or in vitro replicates:
3 females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24/48/72 hours
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 3 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24/48/72 hours
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 2 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24/48/72 hours
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24/48/72 hours
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 2 days
Irritant / corrosive response data:
No iridial effects. Corneal effects were confined to 1 animal 1 and 2 days after application and consisted of slight opacity involving up to 9.25 of the cornea. Conjunctival effects, seen in all animals, consisted of slight or moderate redness for up to 4 days, alight or moderate discharge for up to 1 day and in 1 animal slight or mild chemosis for 1 day.
All signs of irritaion had regressed after 3 days in 1 animal and after 7 days in the other 2 animals.
Other effects:
-pain: slight to moderate initial pain ( class 2-3 on a 0-5 scale)
-eye effects: convoluted eyelids, mucoid discharge, erythema of the eyelids, raised corneal opacity

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DTBA is a mild irritant to the rabbit eye