Fatty acids, tall-oil, reaction products with linseed oil, maleic anhydride and methanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Guideline study under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

minor, not affecting the outcome. Clinical observations made at 4 hours 30 minutes rather than 4 hours after dosing in Step 2. Food replaced in cages at 4 hours 30 minutes rather than at 4 hours, in Step 2.

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

minor, not affecting the outcome. Clinical observations made at 4 hours 30 minutes rather than 4 hours after dosing in Step 2. Food replaced in cages at 4 hours 30 minutes rather than at 4 hours, in Step 2.

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

: Addition product of maleic anhydride, tall oil fatty acids, linseed oil and methanol

IUPAC Name:

: Addition product of maleic anhydride, tall oil fatty acids, linseed oil and methanol

Test material form:

liquid

Details on test material:

UVCB Purity 100% Batch 210150084 Expiry Date 18 May 2016

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories S.r.l.
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: SPF
- Age at study initiation: 6-7 weeks
- Weight at study initiation:157-165g
- Housing:
- Diet (e.g. ad libitum): ad libitum, ssniff SM
- Water (e.g. ad libitum): ad libitum, municipal water supply
- Acclimation period: 5 days
- Indication of any skin lesions: no

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-25
- Humidity (%): 55-57
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: To:TEST ANIMALS

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

PEG 400

Doses:

One dose of 2000 mg/kg body weight was given only once on day 1.

No. of animals per sex per dose:

6 individual female rats were all given the same dose of 2000 mg/kg of body weight.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observations made twice daily. Weights measured at allocation, on the day of dosing and on days 2, 8 and 15.
- Necropsy of survivors performed: yes, on all animals.
- Other examinations performed: no histopathology

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality at the limit dose of 2000 mg/kg bw

Clinical signs:

other: No clinical signs noted

Gross pathology:

No pathology noted

Any other information on results incl. tables

No mortality occurred and no clinical signs were observed in the first group of animals initially dosed at 2000 mg/kg (Group 2, Step 1) and in the further group of 3 females dosed at the same dose level (Group 4, Step 2).

The results indicate that ZWA 5496/100 did not induce toxic effects in any of the rats following oral administration.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral toxicity of the test material is low, with a LD50 greater than 2000 mg/kg body weight. The substance is not classified according to Regulation EC No. 1272/2008.