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

Acute Toxicity: dermal

Administrative data

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.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

data waiving: supporting information

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.

Cross-reference 2

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31 Aug 2004 - 27 Sep 2004

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted in 2002

Deviations:

yes

Remarks:

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted in 2015

Deviations:

yes

Remarks:

no rationale for in vivo testing, no initial testing with one animal

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

December 29th, 1992

GLP compliance:

yes (incl. QA statement)

Remarks:

Groupe Interministeriel des produits chimiques, Paris, Republique Francaise

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste – F40260 Linxe)
- Age at study initiation: not stated
- Weight at study initiation: 2.32 kg - 2.56 kg
- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding
- Diet: not stated
- Water: not stated
- Acclimation period: 7-8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 60-70
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): not stated

IN-LIFE DATES: 31 Aug 2004 - 04 Sep 2004

Type of coverage:

semiocclusive

Preparation of test site:

other: not specified;

Remarks:

undamaged skin area of the right flank

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): as supplied by sponsor

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: Right flank. Size of skin area not specified.
- % coverage: not stated
- Type of wrap if used: The patch was secured in position with a strip of surgical adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not stated

OBSERVATION TIME POINTS
Skin reactions were assessed 1, 24, 48 and 72 hours after removal of the patch

SCORING SYSTEM:
Erythema and Eschar formation: grading scales 0 to 4 (no, slight, definite, moderate, severe)
Oedema: grading scales 0 to 4 (no, slight, slight with contour, moderate, severe)

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3

Remarks:

individual mean over

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Remarks:

individual mean over

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No cutaneous reactions (erythema and oedema) were observed at any examination time in any of the three animals.

Interpretation of results:

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