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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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