sulfuric acids, C9-11-iso-C10 rich, alkyl esters, sodium salt

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted similar to OECD guideline 404. However some deviations occurred (e.g. 24 h occluded exposure, limited data on test substance).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

other: Draize test

Deviations:

yes

Remarks:

e.g. 24 h occluded exposure, limited data on test substance

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: patch-test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO)

Deviations:

no

GLP compliance:

no

Remarks:

Study was conducted prior to implementation of GLP.

Test material

Test material information

Constituent 1

Reference substance name:

Sodium etasulfate

EC Number:

204-812-8

EC Name:

Sodium etasulfate

Cas Number:

126-92-1

Molecular formula:

C8H18O4S.Na

IUPAC Name:

sodium 2-ethylhexyl sulfate

Test animals

Species:

rabbit

Strain:

other: Russian

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.0 to 2.3 kg
- Housing: Individually in metal cages
- Diet (ad libitum): Standard rabbit food - NAFAG Gossau SG
- Water (ad libitum)
- Acclimation period: At least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±1
- Humidity (%): 55±5
- Photoperiod (hrs dark / hrs light): 10/14

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

24 h

Observation period:

7 d

Number of animals:

3 males and 3 females

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 6 animals

Time point:

24/48/72 h

Score:

0.61

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 6 animals

Time point:

24/48/72 h

Score:

0.22

Max. score:

4

Reversibility:

fully reversible within: 48 h

Any other information on results incl. tables

Table 1: Details on results

Observation time	Rabbit No.
	1		2		3		4		5		6
	er	ed	er	ed	er	ed	er	ed	er	ed	er	ed
24 h	1	0	1	0	1	1	1	1	2	1	1	1
48 h	1	0	1	0	0	0	0	0	1	0	1	0
72 h	0	0	0	0	0	0	0	0	0	0	0	0
Mean value 24 + 48 + 72 h	0.67	0	0.67	0	0.33	0.33	0.33	0.33	1.0	0.33	0.67	0.33
Mean value 24 + 48 + 72 h, all animals	0.61	0.22

er: erythema, ed: edema

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified