Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16.04.85-01.05.85
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Deviations:
yes
Remarks:
From current version of OECD 405 (2002): individual body weight at study termination was not reported
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Thiram
EC Number:
205-286-2
EC Name:
Thiram
Cas Number:
137-26-8
Molecular formula:
C6H12N2S4
IUPAC Name:
thiram
Details on test material:
- Name of test material (as cited in study report): TMTD technical
- Physical state: powder
- Analytical purity: 98.8 %
- Impurities (identity and concentrations): water 0.15 %, sodium sulfate 0.35 %, tertamethylthiurame monosulfide 0.21 %. borrebond normal 0.60 %, sodium dodecylbenzenesulfonate 0.10 %
- Lot/batch No.: P53/02-85
- Stability under test conditions: active ingredient very stable after 14 days storage at 55 °C. Aqueous suspension is very stable at pH 6-7
- Storage condition of test material: at ambient temperature in the dark
- Melting point: ~ 140 °C
- Specific gravity: ~ 0.3

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
eyes were not rinsed
Observation period (in vivo):
15 days
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 and 72 h
Score:
0.22
Max. score:
1
Reversibility:
fully reversible within: 15 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
2.17
Max. score:
3
Reversibility:
fully reversible within: 15 days
Irritation parameter:
conjunctivae score
Remarks:
chemosis
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
2.1
Max. score:
3
Reversibility:
fully reversible within: 15 days

Any other information on results incl. tables

The test material is irritating

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU