2,2-dimethylthiazolidine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989-06-14 to 1989-08-15

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

1984

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2-dimethylthiazolidine

EC Number:

242-980-4

EC Name:

2,2-dimethylthiazolidine

Cas Number:

19351-18-9

Molecular formula:

C5H11NS

IUPAC Name:

2,2-dimethylthiazolidine

Details on test material:

Skin irritation - Key, rel1, rabbit, Daamen, 1989:
- Source and lot/batch No.of test material: K90304
- Purity: 98.5 %

eye irritation, Key, rel1, in vitro, Rauh, 2017:
- Analytical purity: 98.9 %
- Source and lot/batch No.of test material: 20150806
- Expiration date of the lot/batch: 21 Sept 2017

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature in the dark
- Stability under test conditions: Stable under storage conditions

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test article was applied undiluted as delivered by the sponsor

Test animals

Species:

rabbit

Strain:

New Zealand White

Remarks:

SPF Quality

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, West-Germany
- Age at study initiation: approx. 13 weeks
- Weight at study initiation: 2.805 - 3.257 kg
- Housing: Individually in cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: At least five days under test conditions.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3°C
- Humidity (%): 30-85%
- Air changes (per hr): 7.5-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1989-06-21 To: 1989-07-12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: adjacent untreated skin area

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted

Duration of treatment / exposure:

4 hours

Observation period:

22 days

Number of animals:

3 females

Details on study design:

TEST SITE
- Approximately 24 hours before treatment, the dorsal fur was shaved with an electric clipper, exposing an area of approximately 100 square centimeters (10 cm x 10 cm).
- Area of exposure: 2x3 cm (surgical gauze patch loaded with test substance)
- Type of wrap if used: surgical gauze patch mounted on an Micropore tape (3M, St. Paul, U.S.A.). The dressing was wrapped around the abdomen and secured with an elastic bandage (Coban, 3M, st. Paul, U.S.A.).

REMOVAL OF TEST SUBSTANCE
- Washing: remaining test substance was removed using a dry tissue and subsequently a tissue moistened with tapwater.
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
The skin reactions were assessed at approximately 60 minutes, 24, 48 and 72 hours and at 7, 14 and 21 days after the removal of the dressings and test article.

SCORING SYSTEM:
- according to Draize, J.H., Woodard, G. and Calvery, H.O., 1944
- Method of calculation: in the study report the PII was calcluated by combining the average skin irritation scores for erythema and oedema after 24 and 72 hours

Note: Where the scoring procedure and the clinical judgement were not in agreement, the assessment of irritancy was based on the latter.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal: #2, #3

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Remarks:

severe effects

Results 3

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal: #2, #3

Time point:

24/48/72 h

Reversibility:

not reversible

Remarks on result:

not determinable

Remarks:

Oedema could not be scored due to eschar formation/crust.

Irritant / corrosive response data:

refer to table with individual findings.

Other effects:

- Other adverse local effects:
A possible corrosive effect was evident on the skin in two animals.
In animal #2 and #3 brown / grey discolouration of the treated skin area at the 60 minutes observation. Subsequent eschar and crust formation.
In the area of application no persistent staining of the treated skin by the test article was observed.

- Other adverse systemic effects:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

2,2-Dimethylthiazolidine: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Erythema	Edema
	Max. score: 4	Max. score: 4
60 min	4/4/4	3/-^a/-^a
24 h	4/4/4	2/-^a/-^a
48 h	4/4/4	2/-^a/-^a
72 h	4/4/4	2/-^a/-^a
7 d	4/4/4	3/-^a/-^a
14 d	0/4/4	0/-^a/-^a
21 d	0/4/4	0/-^a/-^a
Average 24h, 48h, 72h	4/4/4	2/-^a/-^a
Reversibility*)	c/n/n.	c/n/ n.
Average time (unit) for reversion	n.	n.

Note:

a = Oedema could not be scored due to eschar formation/crust.

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Judgment is based on erythema and edema calculated as mean scores for each animal following grading at 24, 48 and 72 hours after removal of the test material, in consideration of reversibility.

The following mean scores were calculated: erythema  4/4/4 and edema  2/-a/-a. In two animals oedema could not be scored due to eschar/crust formation.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (corrosive) based on GHS criteria

Conclusions:

The test material 2,2-dimethyl thiozolidine was severely irritating in the in vivo skin irritation test under the experimental conditions described in this report. A possible corrosive effect was evident on the skin in two animals.
The following 24/48/72 h mean scores were calculated: erythema 4/4/4 and edema 2/-/-. In two animals oedema could not be scored due to eschar/crust formation. The irritation was not reversible within 21 days after exposure in two animals.

Executive summary:

In a primary dermal irritation study, performed according to OECD guideline 404, three Albino rabbits were dermally patch exposed for 4 hours to 0.5 mL of the test substance 2,2-dimethylthiazolidine. Test sites were covered with semi-occlusive dressing. Animals were then observed for consecutive 21 days.

Irritation was scored by the method of DRAIZE. The following 24/48/72 h mean scores were calculated: erythema 4/4/4 and edema 2/-/-. In two animals oedema could not be scored due to eschar/crust formation. The irritation was not reversible within 21 days after exposure.

In this study, 2,2-dimethylthiazolidine is considered to be corrosive to skin according to the criteria of CLP, EU GHS (Regulation (EC) No 1272/2008). Because data is not sufficient for sub-categorisation the substance is classified in Category 1 and has to be labeled with H 314.