1,3,4-Thiadiazolidine-2,5-dithione, reaction products with tert-dodecanethiol and hydrogen peroxide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988-03-15 - 1988-03-22

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well-documented OECD Guideline study without deviations on ‘1,3,4-Thiadiazolidine-2,5-dithione, reaction products with hydrogen peroxide and tert-dodecanethiol’.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according 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:

5-[(2,2-dimethyldecyl)disulfanyl]-1,3,4-thiadiazole-2-thiol; bis[(2,2-dimethyldecyl)disulfanyl]-1,3,4-thiadiazole

EC Number:

939-692-2

Cas Number:

1474044-73-9

Molecular formula:

not applicable (UVCB substance)

IUPAC Name:

5-[(2,2-dimethyldecyl)disulfanyl]-1,3,4-thiadiazole-2-thiol; bis[(2,2-dimethyldecyl)disulfanyl]-1,3,4-thiadiazole

Test material form:

other: liquid

Details on test material:

- Physical state: light brown liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source/Breeder: Interfauna UK Ltd.
- Age: adult animals
- Sex: male
- Weight: 3.1 – 3.4 kg
- Animal Health was examined routinely, only healthy, symptom-free animals were used.
- Identification: by cage number and ear tattoo
- Housing: individually in wire cage type III – high, with a drawer for the faeces below filled with an absorbant, dust-free wood granulate type S 8/15 /Ssniff, Soest
- Diet: Standard diet “ssniff K 4” (Versuchstierdiäten GmbH, Soest/Westfalen), approx. 100-120 g/d and animal
- Water: Tap water, drinking water quality, ad libitum
-Acclimation period: at least 14 d

ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 2°C
- Humidity (%): ca. 50%
- Air changes: ca 10/h
- Photoperiod (hrs dark / hrs light): 12 / 12
- Luminance intensity: ca. 27 Watt/m2

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: Untreated eye served as control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100µL

Duration of treatment / exposure:

24 h

Observation period (in vivo):

7 d

Number of animals or in vitro replicates:

3

Details on study design:

APPLICATION OF TEST SUBSTANCE
100µL of the test item were applied in the conjunctival sac of one eye. The second eye remains untreated as control.

REMOVAL OF TEST SUBSTANCE
- Washing: physiological NaCl-solution
- Time after start of exposure: 24h

SCORING SYSTEM: Draize (as set in OECD Guideline 405)

TOOL USED TO ASSESS SCORE: optical aids / fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: cornea opacity

Basis:

mean

Time point:

other: 1h, 24h, 48h, 72h, 7d

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 2

Irritation parameter:

other: cornea area

Basis:

mean

Time point:

other: 1h, 24h, 48h, 72h, 7d

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1h, 24h, 48h, 72h, 7d

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 4

Irritation parameter:

other: conjunctivae redness

Basis:

mean

Time point:

other: 1h, 24h, 48h, 72h, 7d

Score:

0.2

Max. score:

1

Reversibility:

fully reversible within: 24 hours

Results 5

Irritation parameter:

other: conjunctivae swelling

Basis:

mean

Time point:

other: 1h, 24h, 48h, 72h, 7d

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 6

Irritation parameter:

other: conjunctivae lacrimation

Basis:

mean

Time point:

other: 1 h, 24h, 48h, 72h, 7d

Score:

0.2

Max. score:

1

Reversibility:

fully reversible within: 24 hours

Results 7

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1h, 24h, 48h, 72h, 7d

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 8

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1h, 24h, 48h, 72h, 7d

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 9

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 1h, 24h, 48h, 72h, 7d

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Irritant / corrosive response data:

Under the conditions of this test, the test item was considered to be non-irritating to the eye.

Any other information on results incl. tables

Table 1. Raw data

Animal No.	Observed Endpoint	Draize-Scoring					Mean
		1h	24h	48h	72h	7d
O39 ♂ (3.5kg)	Cornea opacity	0	0	0	0	0	0.0
	Cornea area	0	0	0	0	0
	Iris	0	0	0	0	0	0.0
	Conjunctivae redness	0	0	0	0	0	0.0
	Conjunctivae swelling	0	0	0	0	0	0.0
	Conjunctivae lacrimation	0	0	0	0	0
	Fluorescein	---	n	---	---	---
O44 ♂ (3.1kg)	Cornea opacity	0	0	0	0	0	0.0
	Cornea area	0	0	0	0	0
	Iris	0	0	0	0	0	0.0
	Conjunctivae redness	0	0	0	0	0	0.0
	Conjunctivae swelling	0	0	0	0	0	0.0
	Conjunctivae lacrimation	0	0	0	0	0
	Fluorescein	---	n	---	---	---
N63 ♂ (3.1kg)	Cornea opacity	0	0	0	0	0	0.0
	Cornea area	0	0	0	0	0
	Iris	0	0	0	0	0	0.0
	Conjunctivae redness	1	0	0	0	0	0.2
	Conjunctivae swelling	0	0	0	0	0	0.0
	Conjunctivae lacrimation	1	0	0	0	0	0.2
	Fluorescein	---	n	---	---	---

--- = not examined; n = negative

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Criteria used for interpretation of results: EU-GHS

Conclusions:

The study was conducted according to OECD Guideline 405 and is well-documented. Hence, the study can be considered as valid and the results as reliable (Klimisch 2). Consequently, the test item is considered as not irritating to the eye.

Executive summary:

In an eye irritation study according to OECD Guideline 405 (Bayer AG, Märtins, 1988), 100 µL of the test item (1,3,4-Thiadiazolidine-2,5-dithione, reaction products with hydrogen peroxide and tert-dodecanethiol) was instilled into the conjunctival sac of one eye of each 3 male adult albino rabbits (strain: New Zealand White) for 24 hours. The untreated eye served as control. After the exposure period, the treated eye was washed with physiological saline. The animals were then observed for 7 days. Irritation was scored according to the method of Draize. Except a slight, fully reversible conjunctivae redness and lacrimation 1 h after exposure in one animal, no other effects were observed.