Guerbet alcohols, C24-26, branched and cyclic

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)

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:

Guerbet alcohols, C24-26, branched and cyclic

EC Number:

942-520-9

Cas Number:

2041102-78-5

Molecular formula:

not applicable, UVCB

IUPAC Name:

Guerbet alcohols, C24-26, branched and cyclic

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Envigo RMS srl, San Pietro al Natisone (UD), Italy
- Age at study initiation: 8 to 9 weeks
- Weight at study initiation: 200 to 203 g
- Housing: Clear polysulfone H-Temp solid bottomed cages (Tecniplast Gazzada S.a.r.l., Buguggiate, VA, Italy) measuring 59.5×38×20 cm during acclimatisation period and during the study, with nesting material provided into suitable bedding bags.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
- Method of randomisation in assigning animals to test and control groups

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C±2°C
- Humidity (%): 55%±15%
- Air changes (per hr): Approximately 15 to 20
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: approximately 10 % of body surface
- Type of wrap if used: A patch of surgical gauze covered by a strip of synthetic film was placed over the treated site and the whole assembly held in place by encircling the trunk of the animal with a length of elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

not required

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

no indication of skin irritation up to the relevant limit dose level

Mortality:

none

Clinical signs:

other: none

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Single doses 2000 mg/kg bw of the test substance resulted in no deaths or clinical effects in three female rats. The acute dermal LD50 is therefore > 5000 mg/kg bw.

Executive summary:

The acute toxicity of Guerbet alcohols, C24-26, branched and cyclic was investigated following dermal administration of a single dose to the rat.

One female animal was initially dosed with 2000 mg/kg bw (Range Finding Study). No mortality occurred and no clinical signs were observed. A second group of 2 female animals was then dosed at the same dose level (Main Study). No deaths occurred and no clinical signs were noted. No signs of irritation were observed on treated sites between Day 3 and Day 5 of observation period.

After 14 days, all animals were killed and subjected to necropsy examination. The body weight changes observed during the study were within the expected range for this species and age of animals.

No significant abnormalities were found at necropsy in the animals at termination of the study. No abnormalities were observed at the treated site.

These results indicate that the test item, Guerbet alcohols, C24-26, branched and cyclic, has no toxic effect on the rat following dermal exposure over a 24 hour period at a level of 2000 mg/kg. The lack of mortality and signs of toxicity observed during the study indicates that the median lethal dose is: LD50 cut-off (rat) > 5000 mg/kg/bw.