Registration Dossier

Administrative data

Description of key information

Steaorylchloride is irritationg to the skin but non-irritating to the eye

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets scientific standards with acceptable restrictions (limited documentation, e.g. no details about test substance or applied amount of test substance)
Principles of method if other than guideline:
White Vienna rabbits were used. Usually, 2 animals were treated for 1, 5 and 15 minutes and 2 other animals for 20 hours using occlusive conditions.
An application site of 2.5 X 2.5 cm was covered with the liquid or powdered and moistened test substance. In addition, skin tissue from the ear was
tested by wrapping the ear. These results from the ear, however, would not be taken into account for evaluation as they do not represent testing of the dorsal/lateral flank of the back. After the application time, the skin was washed with water which sometimes contained a mild detergent.
The animals were observed 7 to 8 days and skin changes were recorded on working days. Tests used occlusive dressing, in contrast to the semiocclusive dressing specified by the guidelines.
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): no volume or weight reported. an application site of 2,5 x 2,5 cm was coverd with liquid
Duration of treatment / exposure:
Experiment 1: 1, 5, or 15 minutes
Experiment 2: 20 h
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: An aerea of 2,5 x 2.5 cm of the flank was exposed
- Type of wrap if used: occlusive dressing


REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the exposure time, the skin was washed with 50% Lutrol in water.
- Time after start of exposure: 20 h

SCORING
- see table below
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
20 h occlusive exposure
Time point:
other: 24 h
Score:
ca. 2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
occlusive exposure 20 h
Time point:
other: 24 h
Score:
ca. 2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
20 h occlusive exposure
Time point:
other: 24
Score:
ca. 0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
20 h occlusive exposure
Time point:
other: 24 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 6 days

Since irritation data are recommended for a 4 h skin exposition, results of the available 20 h and the 15 min exposition will serve as approximation.

Descriptive scores of the raw data have been converted to Draize numerical scores.Erythema scoring was at the border of the necrotic aerea.

Exposition:

20 h

Animal

Reading

Erythema

Edema

Comment

1

24 h

2

1

 

2

24 h

2

0

necrosis

1

48 h

2

1

 

2

48 h

2

0

necrosis

1

72 h

2

1

 

2

72 h

1

0

necrosis

1

8 d

0

0

superficial necrosis squamation

2

8 d

0

0

necrosis squamation

mean

24 - 48 h

2.0

0.5

 

 

 

 

 

 

Exposition:

15 min

Animal

Reading

Erythema

Edema

Comment

1

24 h

2

1

 

2

24 h

2

0

 

1

48 h

2

1

 

2

48 h

2

0

 

1

72 h

2

1

 

2

72 h

1

0

 

1

8 d

0

0

squamation

2

8 d

0

0

squamation

mean

24 - 72 h

2.5

3.25

 

Executive summary:

Study meets scientific standards with acceptable restrictions (limited documentation, e.g. no details about test substance or applied amount of test substance). 2 rabbits were treated for 1, 5 and 15 minutes and 2 other animals for 20 hours using occlusive conditions. An application site of 2.5 X 2.5 cm was covered with the liquid or powdered and moistened test substance. After the application time, the skin was washed with water which sometimes contained a mild detergent. The animals were observed 8 days and skin changes were recorded on working days. Marked erythema, slight edema and minimal necrotic effects were obseved afte 20 h occlusive exposure. Marked erythema, slight edema but not any necrotic effects were see after 15 min exposure.

Conclusion

The test substance was graded irritating. Minor necrotic effects after 20 h occlusive exposure were judge to be due to the more stringent test procedure in comparisson to a OECD Guideline study.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study is comparable to OECD Guideline 405 with acceptable restrictions (partly limited documentation, e.g. no details about the test substance; 50 μl instead of 100 μl test substance instilled; scoring system not according to OECD405). Study sufficient for evaluation of this endpoint.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
only 50 µl; no washing after 24 h
Principles of method if other than guideline:
White Vienna rabbits were used. Usually 50µl or mg of the test substance were applied to the conjunctival sac of one eye of 2 animals. The non- or saline-treated adjacent eye served as a control. The animals were observed several times on the treatment day and up to 7 or 8 days afterwards, and findings were recorded on working days. The eyes were not washed out after 24 hours as specified in OECD Guideline 405.
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl
Observation period (in vivo):
study terminated afte 48 h
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM
see table below

TOOL USED TO ASSESS SCORE
fluorescein at the end of the study
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-48 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-48 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-48 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
slight erythema (1), and a minimal/questionable edema was observed 3 h after application. The effects were fully reversible with in 1 day. The study was terminated after negative fluorescein staining 48 h after application
Other effects:
Traces of blood were visible 3 h after application in both animals. The finding may be due to attemps of the animals to clean their eyes.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Because of the full reversibility of the minimal effects observed within the first 3 h after application the substance is classified as non- irritating.
Executive summary:

The study is comparable to OECD Guideline 405 with acceptable restrictions. White Vienna rabbits were used. 50µl of the test substance were applied to the conjunctival sac of one eye of 2 animals. The eyes were not washed out after 24 hours.

No effects were observed 24 h after application

Conclusion

Because no effects were observed 24 h after application the substance is classified as non- irritating.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation was tested using an internal standard method (BASF test). This study meets scientific standards with acceptable restrictions (limited documentation).Whiterabbits were used. 2 animals were treated for 1, 5 and 15 minutes and for 20 hours using occlusive conditions. An application site of 2.5 x 2.5 cm was covered with the test substance. Marked erythema, slight edema and superficial necrotic effects were observed after 20 h occlusive exposure.Marked erythema, slight edema but not any necrotic effects were see after 15 min exposure. The test substance was graded irritating. Minor necrotic effects after 20 h occlusive exposure were judge to be due to the more stringent test procedure in comparisson to a OECD Guideline study.

Eye irritation was examined in a study comparable to OECD Guideline 405 with acceptable restrictions (limited documentation, reduced application volume). The study is however sufficient for evaluation of this endpoint. No effects were observed 24 h after application


Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Based on the available data a classification concerning skin irritation is warranted: Skin Irrit. Cat. 2 according to Annex I of Regulation EC/1272/2008 (CLP). The substance is non irritating to the eyes.