Reaction product of Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs. and Benzenesulfonic acid, 4-methyl- and sodium hydroxide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987-04-22 to 1987-05-14

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction product of Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs. and Benzenesulfonic acid, 4-methyl- and sodium hydroxide

EC Number:

932-051-8

Molecular formula:

not available - not a single isomer - see remarks

IUPAC Name:

Reaction product of Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs. and Benzenesulfonic acid, 4-methyl- and sodium hydroxide

Details on test material:

- Name of test material (as cited in study report): Marlon ARL (Reaction product of Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs. and Benzenesulfonic acid, 4-methyl- and sodium hydroxide)
- Physical state: solid (powder)
- Storage condition of test material: not mentioned
- Date of production: 1987-03-24
pH (20 g/L): 8 - 10

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 - 2.6 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:

water

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 0.5 g of the test material was wetted with 0.5 cm³ deionised water

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 cm³

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48, 72 h, 6, 8, 10, 14 d after exposure
One anmial was testes with 0.5 g test substance without water.

Number of animals:

3

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, the application area was then immobilised with an elastic dressing


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


SCORING SYSTEM: according to OECD guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 1 h

Score:

7.33

Max. score:

8

Reversibility:

not reversible

Remarks on result:

other: in part deep skin changes

Results 2

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 h, 48 h, 72 h

Score:

7.67

Max. score:

8

Reversibility:

not reversible

Remarks on result:

other: in part deep skin changes, hardening at the application point

Irritant / corrosive response data:

AVERAGE SCORE
- Erythema: 3.67
- Edema: 4

Other effects:

after 6 d: 3 animals had crusts, one of them cracked
after 8 d: 3 animals had crusts, one of them erythema, two were in loosening, one also got new skin
after 10 d: 3 animals had crusts, one loosed, in part loosening, one had a little scar
after 14 d: 3 animals had new skin, one of them with the little scar, one still with a crust on the rand, one with a rest of crust in loosening

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: 4	Max. score: 4
60 min	4/3/3	4/4/4
24 h	4/4/3	4/4/4
48 h	4/4/3	4/4/4
72 h	4/4/3	4/4/4
Average 24h, 48h, 72h	3.67	4.0
Reversibility*)	n	n

 

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

 

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Executive summary:

The skin irritation of 0.5 g of the reaction product of Benzenesulfonic acid, C10-13-alkyl derivs and toluenesulfonic acid and sodium hydroxid in 0.5 cm³ water was investigated. The irritation index was 7,59/8. Therefore Marlon ARL is regarded as highly irritating.