Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Sodium dimethyldithiocarbamate
EC Number:
204-876-7
EC Name:
Sodium dimethyldithiocarbamate
Cas Number:
128-04-1
IUPAC Name:
sodium dimethyldithiocarbamate
Constituent 2
Reference substance name:
SDMC
IUPAC Name:
SDMC

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, Moston. Sandbach, Cheshire. UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2-3.5 kg
- Housing: individually in suspended metal cages
- Diet: STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK, ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
water
Controls:
other: untreated eye served as a concurrent control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml of 41.44% aqueous solution
- Concentration (if solution): 0.1 ml

Duration of treatment / exposure:
Single instillation
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: ophthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 + 48 + 72 hr
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 + 48 + 72 hr
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 + 48 + 72 hr
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 + 48 + 72 hr
Score:
0.4
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
No corneal or iridial effects were noted during the study.
Moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal to moderate conjunctival irritation at the 24 and 48-hour observations. Minimal conjunctival irritation was noted in one treated eye at the 72-hour observation. Two treated eyes appeared normal at the 72-hour observation and one treated eye appeared normal at the 7-day observation.
Discharge from the nose and mouth was noted in one animal at the 24, 48 and 72-hour observations.
Other effects:
Initial pain response in the first animal was 3 on the scale of 6 (moderate initial pain). Therefore one drop of local anaesthetic was instilled into both eyes of two additional test animals 1 to 2 minutes before treatment. No initial pain response was observed in these rabbits.

Applicant's summary and conclusion