citric acid, esters with dodecan-1-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 1997-06-23 to 1997-08-25

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study, read-across

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-Hydroxypropane-1,2,3-tricarboxylic acid, tri (hexyl, octyl, decyl) ester

IUPAC Name:

2-Hydroxypropane-1,2,3-tricarboxylic acid, tri (hexyl, octyl, decyl) ester

Constituent 2

Reference substance name:

-

EC Number:

430-290-8

EC Name:

-

Details on test material:

- Name of test material (as cited in study report): LINPLAST 86 CT
- Substance type: pure active substance
- Physical state: liquid
- Stability under test conditions: no data
- Storage condition of test material: at room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sulzfeld, Germany
- Age at study initiation: 39 days (males); 48 days (females)
- Weight at study initiation: 164 - 200 g (males); 155 - 184 g (females)
- Fasting period before study: approx. 16 hours
- Housing: in groups of 2 - 3 animals in Makrolon cages type III on granulated textured wood bedding
- Diet (e.g. ad libitum): Altromin 1324 (Standard diet for rats and mice) ad libitum, supplied by Altromin GmbH, Lage/Lippe, Germany
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 60 ± 20
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.8 % aqueous hydroxypropylmethylcellulose gel (METHOCEL E 4 M, Synopharm, Barsbüttel, Germany)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: The test substance was diluted to the appropriate concentration for dose levels 1 - 4 (2000, 6000, 10000 and 20000 mg/kg), for group 5 (50000 mg/kg) the test substance was used as supplied), no further details mentioned.
- Amount of vehicle (if gavage): no data
- Justification for choice of vehicle: not justified
- Lot/batch no. (if required): MM90100512E
- Purity: no data


MAXIMUM DOSE VOLUME APPLIED: group 1 - 4: 20 mL/kg bw; group 5: 50 mL/kg bw

Doses:

2000 / 6000 / 10000 / 20000 / 50000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 h after administration and thereafter daily. Individual boy weights were recorded before administration of the substtance , thereafter in weekly intervalls.
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical signs concerning changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern were examined, attention was also paid to possible tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

Statistics:

No statistics performed, due to lack of mortality in this study.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 50 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortality occurred

Clinical signs:

no clinical signs observed

Body weight:

normal body weight gain achieved

Gross pathology:

no test substance related findings noted

Any other information on results incl. tables

Table: Number of animals dead [and with evident toxicity] [and time range within which mortality occurred]

 

Dose (mg/kg bw)	Mortality (# dead/total)			Time range of deaths (hours)	Number with evident toxicity(#/total)
	Male	Female	Combined		Male	Female	Combined
2000	0/5	0/5	0/10	-	0/5	0/5	0/10
6000	0/5	0/5	0/10	-	0/5	0/5	0/10
10000	0/5	0/5	0/10	-	0/5	0/5	0/10
20000	0/5	0/5	0/10	-	0/5	0/5	0/10
50000	0/5	0/5	0/10	-	0/5	0/5	0/10

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the present test condition a single oral administration of up to 50000 mg/kg b.w. to rats revealed no toxic symptoms. 50000 mg/kg equivalent to an application volume of 50 mL/kg was the highest reasonable application volume. The test substance was classified to be relatively non-toxic.

Executive summary:

The test item was investigated according to OECD Guideline 401. The test subsatnce was administered to once orally to male and female Sprague-Dawley rats by gavage a doses up to 50000 mg/kg b.w. Subsequently, observations of effects and deaths were made. All surviving animals were observed for a period of 14 days.

Under the present test condition a single oral administration of up to 50000 mg/kg b.w. to rats revealed no toxic symptoms. 50000 mg/kg equivalent to an application volume of 50 mL/kg was the highest reasonable application volume. The test substance was classified to be relatively non-toxic.