Tetramethylthiuram monosulphide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Reference 2

Reference Type:

publication

Title:

Acute Toxicologic Evalutation of Tetramethyl thiuram monosulphide

Author:

Bombard E, Löser E

Year:

1996

Bibliographic source:

J.Am.Coll.Toxicol., Vol 15, Suppl 1

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

tetramethylthiuram monosulfide

IUPAC Name:

tetramethylthiuram monosulfide

Constituent 2

Reference substance name:

Tetramethylthiuram monosulphide

EC Number:

202-605-7

EC Name:

Tetramethylthiuram monosulphide

Cas Number:

97-74-5

Molecular formula:

C6H12N2S3

IUPAC Name:

N,N-dimethyl[(dimethylcarbamothioyl)sulfanyl]carbothioamide

Test material form:

solid: particulate/powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: W.Ostrop/Meerbusch
- Age at study initiation: no data
- Weight at study initiation: 2.9 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7-14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18 °C
- Humidity (%): 40%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

100 µl

Duration of treatment / exposure:

24h

Observation period (in vivo):

24-48-72h, 8 days

Number of animals or in vitro replicates:

6 rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE : no
SCORING SYSTEM: Draize score
TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

6 rabbits

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

6 rabbits

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Remarks:

6 rabbits

Time point:

24/48/72 h

Score:

0.44

Max. score:

3

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: Individual scores = 1-0-0.33-0.33-0 -1

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

6 rabbits

Time point:

24/48/72 h

Score:

0.22

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: Individual scores = 0.33-0-0-0.33-0-0.66

Irritant / corrosive response data:

No effect was observed on cornea and iris. Very slight effects on conjunctivae were observed, and are fully reversible in 8 days.

Other effects:

no

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Not eye irritating

Conclusions:

According to these results, TMTM was considered as not irritating for eyes in rabbits.

Executive summary:

Tetramethylthiuram monosulfide was placed in the conjunctival sac of one eye of each of six albino rabbits. The irritant reactions were scored until complete recovery. Some of the instilled powder was retained within the eye for at least 24 hours.

No effect was observed on cornea and iris. Very slight effects on conjunctivae were observed, and are fully reversible in 8 days. According to these results, TMTM was considered as not irritating for eyes in rabbits.