Sulfuric acid, C12-14 (even numbered)-alkyl esters, (2-hydroxylpropyl)ammonium salts

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 June 2012 - 30 August 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium octyl sulphate

EC Number:

205-535-5

EC Name:

Sodium octyl sulphate

Cas Number:

142-31-4

Molecular formula:

C8H18O4S.Na

IUPAC Name:

sodium octyl sulfate

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Details on strain: Wistar / Crl:WI (Han) SPF
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: approx. 9 weeks (males) and 13 weeks (females), respectively
- Weight at study initiation: mean (males): 273.0 ± 6.63g; mean (females): 225.8 ± 3.19g
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: single housing in Makrolon cage, type III
- Diet (ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany
- Water (ad libitum): Tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22°C ± 3°C
- Humidity: 30 – 70%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Remarks:

deionized water

Details on dermal exposure:

TEST SITE
- Area of exposure: clipped epidermis (dorsal and dorsolateral parts of the trunk)
- % coverage: about 40 cm² (corresponds to at least 10% of the body surface)

REMOVAL OF TEST SUBSTANCE
- Washing: rinsing of the application site with warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5.71 mL/kg bw
- Concentration (if solution): 35 g/100 mL
- Constant volume or concentration used: yes
- For solids, paste formed: no
- Form of application: solution in deionized water
- Test item preparation and homogenization: For better handling the test item was ground with mortar and pestle. The test item preparation was produced shortly before application by stirring with a magnetic stirrer.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: A check for any dead or moribund animals was made at least once each workday.
- Necropsy of survivors performed: yes
- Other examinations performed:
Clinical signs: Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals.

Scoring of skin findings: Individual readings 30 – 60 minutes after removal of the semi-occlusive dressing (day 1), weekly thereafter and on the last day of observation.
The evaluation of skin reactions was performed according to Draize, J.H. (1959): Appraisal of the safety of chemicals in foods, drugs and cosmetics. The association of food and drug officials of the United States Austin, Texas.

Body weight: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.

Pathology: Necropsy with gross-pathology examination on the last day of the observation period after sacrifice with CO2 in a chamber with increasing concentrations over time.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

No systemic clinical signs were observed during clinical examination.

Body weight:

Males:
The mean body weight of the male animals increased within the normal range throughout the study period.

Females:
The mean body weight of the female animals did not significantly change during the first post-exposure observation week, probably due to the bandage procedure, but increased during the second week within the normal range.

Gross pathology:

There were no macroscopic pathological findings in the animals sacrificed at the end of observation period.

Other findings:

Local effects:
No local effects were observed.

Any other information on results incl. tables

Body weight changes:

Individual body weight changes
Dose [mg/kg bw]	2000
Sex	male
Animal No.	1	2	3	4	5	mean	sd.
Body weight at study day [g]
0	274	267	282	266	276	273.0	6.63
7	278	284	301	281	285	285.8	8.93
14	307	304	330	299	308	309.6	11.93

 

Individual body weight changes
Dose [mg/kg bw]	2000
Sex	female
Animal No.	1	2	3	4	5	mean	sd.
Body weight at study day [g]
0	224	222	230	225	228	225.8	3.19
7	231	220	234	226	230	228.2	5.40
14	237	238	240	239	238	238.4	1.14

sd. = standard deviation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

CLP: not classified