Fatty acids, C7-9, tetraesters with pentaerythritol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

07. Dec. - 23. Dec. 1998

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP-Guideline study with acceptable restrictions (no analytical purity reported)

Justification for type of information:

refer to analogue justification provided in IUCLID section 13

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

yes

Remarks:

no analytical purity reported

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

yes

Remarks:

no analytical purity reported

GLP compliance:

yes (incl. QA statement)

Remarks:

Safepharm Laboratories Limited, Derby, UK

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

131459-39-7

Cas Number:

131459-39-7

IUPAC Name:

131459-39-7

Test animals

Species:

rat

Strain:

other: Sprague-Dawley CD (Crl:CD® (SD) IGS BR)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 234 - 237g (males), 215 - 220g (females)
- Housing: in groups of up to 3 by sex in solid-floor polypropylene cages
- Diet: rat and mouse Diet No.1, Special Diets Services Limited, Witham, Essex, UK, ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21
- Humidity (%): 37 - 67
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.09 mL/kg

DOSAGE PREPARATION: The specific gravity was determined and used to calculate the appropriate dose volume for the required dose level.

CLASS METHOD
- Rationale for the selection of the starting dose: The available information suggested the starting dose.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for death or overt signs of toxicity 0.5; 1; 2 and 4 hours after dosing and subsequently once daily; individual body weights were determined prior to dosing, on day 7 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.

Gross pathology:

Necropsy and histopathological examination revealed no substance-related finding.

Any other information on results incl. tables

Table 1: Bodyweight gain

Dose level		Bodyweight [g] at Day
mg/kg bw	female	0	7	14
2000	1-0	220	259	280
	1-1	217	251	258
	1-2	215	249	272
	male
	2-0	235	307	348
	2-1	237	300	343
	2-2	234	298	343

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

CLP: not classified