Fatty acids, coco, esters with 1,3-butanediol

Endpoint summary

Description of key information

Oral (OECD 423): LD50 rat > 2000 mg/kg bw

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:

24 Aug 2004 - 16 Sep 2004

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted in 1996

Deviations:

yes

Remarks:

, lack of details (test substance, animals, housing)

Qualifier:

equivalent or similar to guideline

Guideline:

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

Version / remarks:

adopted in 2002

Deviations:

yes

Remarks:

, the study was conducted in 2004 following the guideline adopted in 1996, although the guideline had been updated in 2002

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

adopted in 1996
Directive N° 96/54/EC

GLP compliance:

yes (incl. QA statement)

Remarks:

Groupe Interministeriel des produits chimiques, Paris, Republique Francaise

Test type:

acute toxic class method

Limit test:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Expiration date of the lot/batch: not stated
- Purity test date: not stated

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not stated
- Stability under test conditions: not stated
- Solubility and stability of the test substance in the solvent/vehicle: not stated

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle, France)
- Females (if applicable) nulliparous and non-pregnant: not stated
- Age at study initiation: not stated
- Weight at study initiation: 181g to 196g (males) and 168g to 185g (females)
- Fasting period before study: not stated
- Housing:not stated
- Diet: A04 Rat and mouse maintenance diets
- Water: not stated
- Acclimation period: 5-6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 55-70
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): not stated

IN-LIFE DATES: From: 24 August 2004 To: 08 September 2004

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE: none
MAXIMUM DOSE VOLUME APPLIED: 2.19 mL/kg body weight
ROUTE OF ADMINISTRATION: oral gavage (using a suitable syringe graduated fitted with an oesophageal metal canula)

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

yes

Remarks:

Distilled water at 2 mL/kg bw

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily from day 1 to day 14
- Frequency of weighing: day 0, day 2, day 7, day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs at 1, 3, and 5 hours after oral administration on day 0

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study.

Clinical signs:

other: No clinical signs related to the administration of the test product were observed.

Gross pathology:

The macroscopical examinations of the animals at the end of the study did not reveal treatment-related changes.

Other findings:

No abnormalities regarding spontaneous activity, Preyer’s reflex (noise), respiratory rate, convulsions, tremors, body temperature, muscle tone, palpebral opening, pupil appearance, salivation, lacrimation, righting reflex, back hair appearance assessed at 1, 3, and 5 hours after oral administration.

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The available information comprised an adequate and reliable study (Klimisch score 2), sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No. 1907/2006.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Justification for type of information:

No study was conducted as the exposure of humans via inhalation was judged unlikely taking into account the very low vapour pressure of the liquid substance Fatty acids, coco, esters with 1,3-butanediol (CAS 73138-39-3). The vapour pressure of the liquid substance Fatty acids, coco, esters with 1,3-butanediol (CAS 73138-39-3) was calculated to be below <1 x 10-5 kPa (7.5 x 10-5 mmHg) at 20 °C; thus being of low volatility.

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

The target substance Fatty acids, C12-18, esters with 1,3-butanediol (CAS 73138-39-3) did not cause mortality or adverse clinical signs in an acute toxicity study following oral administration of 2000 mg/kg bw in male and female rats. Furthermore, no systemic effects were noted in the in vivo skin irritation study performed with Fatty acids, C12-18, esters with 1,3-butanediol (CAS 73138-39-3). Hence, testing for acute dermal toxicity should be avoided for reasons of animal welfare especially as no additional knowledge is expected to be gained by an acute dermal toxicity study considering the outcome of the available, relevant studies.

Reason / purpose for cross-reference:

data waiving: supporting information

Reason / purpose for cross-reference:

data waiving: supporting information

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute oral toxicity

The acute oral toxicity of Fatty acids, coco, esters with 1,3-butanediol (CAS 73138-39-3) was assessed in a study according to OECD guideline 423 (key study, 2004). Administration of 2000 mg/kg bw to 3 male and 3 female Sprague-Dawley rats via the oral gavage route did not cause mortality and no clinical signs were recorded during the 14-day observation period. No adverse effects were observed.

Overall conclusion for acute toxicity

The available data indicate a very low level of acute toxicity following the oral route and thus Fatty acids, coco, esters with 1,3 -butanediol (CAS 73138 -39 -3) is not considered to be hazardous following acute oral exposure.

Justification for classification or non-classification

The available data on acute toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.