Sodium cumenesulphonate

Skin irritation / corrosion

Administrative data

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Sodium cumenesulphonate

EC Number:

248-983-7

EC Name:

Sodium cumenesulphonate

Cas Number:

28348-53-0

Molecular formula:

C9H12O3S.Na

IUPAC Name:

sodium cumenesulphonate

Test material form:

solid

Specific details on test material used for the study:

CAS Number: 28348-53-0
Identity: Cumene sulfonic acid, sodium salt
Purity: 96.0%
Remarks: 60% aqueous solution

Test animals

Species:

rabbit

Strain:

other: Small White Russian

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 2.2 - 2.4 kg
- Housing: single housing in stainless steel cages
- Diet (e.g. ad libitum): Ssniff K4 complete feed for rabbits, ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: Aqua dist.

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 cm³
-Concentration: 60% in aqua dist. (paste)

Duration of treatment / exposure:

4 hours

Observation period:

72 hours after patch removal

Number of animals:

6 (3 male, 3 female)

Details on study design:

TEST SITE
- Area of exposure: 6 cm² of shaved skin of the dorsal and lateral parts of the trunk of the animals
- % coverage: not mentioned
- Type of wrap if used: on the application area a mull patch (2,5 x 2,5 cm) was placed, which was covered with a polyethylen film (6 x 6 cm). The application area was then immobilised with an elastic dressing


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with distilled water
- Time after start of exposure: 4 hours


SCORING SYSTEM: according to OECD guideline 404

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritant / corrosive response data:

AVERAGE SCORE
- Erythema: 0
- Edema: 0

Any other information on results incl. tables

Table: Irritant/corrosive response data for each animal at each observation time of each animal from the test

 

Score at time point / Reversibility	Erythema	Edema
	Max. score:	Max. score:
60 min	0/0/0/0/0/0	0/0/0/0/0/0
24 h	0/0/0/0/0/0	0/0/0/0/0/0
48 h	0/0/0/0/0/0	0/0/0/0/0/0
72 h	0/0/0/0/0/0	0/0/0/0/0/0
Average 24h, 48h, 72h	0	0
Reversibility*)	-	-
Average time (unit) for reversion

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The test substance was not irritating to skin. No irritation was observed; all scores were “0”.

Executive summary:

The test substance was not irritating to skin. No irritation was observed; all scores were “0”.