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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 November 1985- 09 December 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was not performed under GLP. OECD 404 was followed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Chemical name: disodium tetrasulphide (natriumtetrasulfid)
Appearance: Yellow-brown solid

No CoA included in the study, no information on purity and composition of the test substance. For additional information see attached document.

Test animals

Species:
rabbit
Strain:
other: White Russen (albino)
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Asta-Werke AG, D-4800 Bielefeld 14
- Age at study initiation: 6 - 11 months
- Weight at study initiation: 2.2 - 2.5 kg
- Fasting period before study: Not applicable.
- Housing: steel cages, bar floor, model asta. One animal per cage.
- Diet (e.g. ad libitum): Ad libitum, standard food for rabbits, ssniff(K).
- Water (e.g. ad libitum): Ad libitum.
- Acclimation period: minimal 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: 25 November 1985- 09 December 1985

Test system

Type of coverage:
occlusive
Preparation of test site:
other: 2 sites are shaved and 2 sites are shaved and abraded
Vehicle:
water
Controls:
other: 2 sites with untreated skin are used a control sites
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 grams
- Concentration (if solution): the test substance was moistened with 0.15 ml water
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3 males
Details on study design:
TEST SITE
On the back of the animals 4 sites were created. The whole area was shaved. 2 sites were also abraded. 1 shave and 1 abraded site was exposed to the test substance.
- Area of exposure: on the back of the animals between shoulder and hipbone.
- % coverage: 6.25 cm2
- Type of wrap if used: occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data

SCORING SYSTEM: Draize (1944)
Erythema and eschar formation
0 No erythema
1 Very slight erythema (barely perceptible)
2 Well defined erythema
3 Moderate to severe erythema
4 Severe erythema (beet redness) to slight eschar formation (injuries in depth)

Oedema formation
0 No oedema
1 Very slight edema(barely perceptible)
2 Slight edema(edges of the area well defined by definite raising)
3 Moderate edema(raised approximately 1mm)
4 Severe edema( raised more than 1 mm and extending beyond the area of exposure)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
see remark on results
Basis:
other: see remark on results
Time point:
24/48/72 h
Score:
> 4
Max. score:
4
Reversibility:
not reversible
Remarks:
see remark on results
Remarks on result:
other: Since corrosion was observed average scores were not calculated.
Irritation parameter:
edema score
Remarks:
see remark on results
Basis:
other: see remark on results
Time point:
24/48/72 h
Score:
> 4
Max. score:
4
Reversibility:
not reversible
Remarks:
see remark on results
Remarks on result:
other: Since corrosion was observed average scores were not calculated.
Irritant / corrosive response data:
After removal of the patches the skin showed green to grey/black, shiny discoloration. The edges of the apllication area was discolored white.

Erythema was oberved 24 after the end of the application (in the results tabele it is already scored after 1 hours and given score 3 so this is not correct in the report). The redness was spread over the backs of the animals. Corrosion was observed, 2-4 millimeter deep corrison was observed. Scabs were observed after 14 days.

Oedema was seen immediatly after patch removal (score 3). In the second week the oedema had reversed.

See table 1.
Other effects:
Systemic effects were not observed.

Any other information on results incl. tables

Table 1. Summary of dermal lesions (following 4-h application) on intact skin

 

no.

Effect

Hour

Days after application

Mean score erythema

24/48/72 h

Mean score oedema

24/48/72 h

1

1

2

3

7

14

 

 

 

1

Erythema/ eschar

Oedema

3

 

3

3

 

2

3

 

1

3

 

1

 

**

 

***

***

2

Erythema/ eschar

Oedema

*

 

4

3

 

4

3

 

3

3

 

3

 

**

 

***

***

3

Erythema/ eschar

Oedema

*

 

4

3

 

3

3

 

2

3

 

2

 

**

 

***

***

Mean

 

 

 

 

 

 

 

 

 

 

* due to severity of the effects skin could not be scored.

** after 14 days scabs were observed. Half way during the second week the oedema was reduced.

*** since the test substance has a corrosive effect on the skin the average scores were not calculated.

 

The untreated control skin showed no effects. Results of the abrade skin are not shown.

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Corrosion was observed in all animals after a 4 hour exposure < 14 days. If corrosion would occur after 3 minutes or 1 hour exposure cannot be judged e.g category 1A or 1B is in place. The substance is classified by the EU in category 1B therfore that C&L is taken over here.
Executive summary:

According to OECD404 a skin irritation study was performed in rabbits. 3 animals were used. On the back of the animals 4 sites were created. The whole area was shaved. 2 sites were also abraded. 1 shave and 1 abraded site was exposed to the test substance. the sites were exposed to 0.5 grams under occlusion. After removal of the patches the skin showed green to grey/black, shiny discoloration. The edges of the apllication area was discolored white.

Erythema was oberved 24 after the end of the application (in the results tabel it is already scored after 1 hours and given score 3 so this is not correct in the report). The redness was spread over the backs of the animals. Corrosion was observed, 2-4 millimeter deep corrison was observed. Scabs were observed after 14 days.

Oedema was seen immediatly after patch removal (score 3). In the second week the oedema had reversed.

Corrosion was observed in all animals after a 4 hour exposure < 14 days.