Alcohols, C11-15-secondary, ethoxylated

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 February 1997 to 10 March 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Conducted to internationally accepted guidelines and to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

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:

Alcohols, secondary C11-15, ethoxylated

EC Number:

614-295-4

Cas Number:

68131-40-8

Molecular formula:

C(11-15) H(23-31) O (C2H4O)xH where n= approximately 3

IUPAC Name:

Alcohols, secondary C11-15, ethoxylated

Details on test material:

- Name of test material (as cited in study report): SOFTANOL 30
- Physical state: Liquid, slightly yellow
- Analytical purity: >99% by wt.
- Lot/batch No.: W70127
- Expiration date of the lot/batch: 27 June 1997
- Storage condition of test material: at room temperature {approx. 20°C, away from direct sunlight)

Test animals

Species:

rat

Strain:

other: HanIbm: WIST

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wolferstrasse 4, CH-4414 Fullinsdorf, Switzerland
- Age at study initiation: (age when treated) males 8 weeks, females 11 weeks
- Weight at study initiation: (when treated) Males: 225.2 - 240.3 8, Females: 191.9- 223.8 g
- Fasting period before study: no
- Housing: During acclimatization in groups of five in Makrolon type-4 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz). During treatment and observation individually in Makrolon type-3 cages with standard softwood bedding.
- Diet (e.g. ad libitum): Pelleted standard Kliba 343, batch 81/96 rat maintenance diet (Kliha Muhlen AG, CH-4303 Kaiseraugst) available ad libitum.
- Water (e.g. ad libitum): Community tap water from Itingen, available ad libitum.
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 4-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 17 February 1997 To: 10 March 1997

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Back (clipped)
- % coverage: 10
- Type of wrap if used: A semi-occlusive dressing wrapped around the abdomen and fixed with an elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed with lukewarm tap water and dried with disposable paper towels.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0 mL
- Concentration (if solution): 100%
- Constant volume or concentration used: yes

Duration of exposure:

24 Hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Four times during test day 1 and once daily for surviving animals during days 2-15. Weighing: On test day 1 (pre-administration), 8 and 15 for surviving animals.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: Each animal was examined for changes in appearance and behaviour (with special emphasis on the application area, except for the time when the semi-occlusive dressing was in place) four times during day 1, and once daily for surviving animals during days 2-15. All abnormalities were recorded.

Statistics:

The LOGIT-Model could not be used as no deaths occurred.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the study.

Clinical signs:

other: No clinical signs of systemic toxicity of the test article on the skin at the application site were observed during the observation period. Local effects such as general erythema and scales on the back were observed in all animals.

Gross pathology:

No macroscopic organ findings were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

Migrated information: or unclassified (CLP)

Conclusions:

LD50 for male and female rats was >2000 mg/kg.

Executive summary:

In an acute dermal toxicity study realised according to the OECD guideline 402 and in compliance with GLP, groups of 5 male and 5 female rats were dermally exposed to undiluted Softanol 30 for 24 hours to 10% of body surface area (back) at doses of 2000mg/kg bw. Animals then were observed for 14 days. 

No deaths occurred during the study. No clinical signs of systemic toxicity of the test article on the skin at the application site were observed during the observation period. Local effects such as general erythema and scales on the back were observed in all animals. LD50 for male and female rats was >2000 mg/kg.