Guerbet alcohols, C24-26, branched and cyclic

Endpoint summary

Description of key information

An acute oral toxicity study with the substance Guerbet alcohols, C24-26, branched and cyclic show a very low acute oral toxicity. No mortalities nor clinical signs were observed at doses of 2000 mg/kg bw in rats. No pathological findings were observed at dissection of the animals.

An acute dermal toxicity study of Guerbet alcohols, C24-26, branched and cyclic in rats show a low dermal toxicity at doses of up to 2000 mg/kg.

No mortalities occurred and no clinical signs were observed following a dermal exposure of 24 h.

Based on the available data it can be concluded that the substance Guerbet alcohols, C24-26, branched and linear has a very low acute oral and dermal toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August to October 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

17 December 2001

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage JANVIER LABS (53940 Le Genest St Isle, France)
- Age at study initiation: 8 weeks
- Weight at study initiation: 187-210 g
- Fasting period before study: on day of dosing until 4 hours after dosing
- Housing: single in Macrolon cages (type II)
- Diet : A04, SAFE (ad libitum)
- Water: tap water (ad libitum)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70 %
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: September 8, 2015 To: September 23, 2015

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

single application by gavage

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: body weights were determined before the study and on days 2, 7 and 14

Statistics:

no

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: none

Gross pathology:

The macroscopic examination of the animals did not reveal treatment related changes.

Interpretation of results:

GHS criteria not met

Conclusions:

The substance Guerbet alcohols, C24-26, branched and cyclic is practically nontoxic after oral administration of 2000 mg/kg bw to rats.

Executive summary:

The substance Guerbet alcohols, C24-26, branched and cyclic is practically nontoxic after oral administration to rats. No mortality occured after oral administration of 2000 mg /kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

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

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

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

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Justification for classification or non-classification

Available data are conclusive but not sufficient for classification of Guerbet alcohols, C24-26, branched and linear with regard to acute toxicity.