Glycerides, mixed C8-10 and succinyl

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given. Lack of details on the test material and limited documentation.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

lack of details on the test material and limited documentation

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Glycerides, mixed C8-10 and succinyl

EC Number:

294-620-0

EC Name:

Glycerides, mixed C8-10 and succinyl

Cas Number:

91744-56-8

Molecular formula:

Not applicable: Complex UVCB substance

IUPAC Name:

Glycerides, mixed C8-10 (even numbered) and succinyl

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Physical state: clear oil-like material
- Analytical purity: no data

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Bantin & Kingman Ltd., Hull, UK
- Weight at study initiation: 150 ± 20 g
- Housing: animals were housed individually in grid-floor cages.
- Diet: standard laboratory rodent diet (41B pellets) (Dixon & Sons. (Ware) Ltd., Ware, UK), ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: clipped skin of the backs and flanks
- Type of wrap if used: the treated area was covered with a strip of impermeable adhesive tape, lined with aluminium foil. The stripe encircled the trunk of the animals to achieve complete occlusion of the application site.

REMOVAL OF TEST SUBSTANCE
- Washing: residual test substance was removed by washing with a mild aqueous detergent solution, rinsing and drying with paper tissue.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 0.76 mL (mean volume calculated from the mean initial body weight of 152.1 g and a dose of 5 mL/kg bw)

Duration of exposure:

24 h

Doses:

5 mL/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed immediately after administration and daily thereafter. Any deaths or signs of toxicity were recorded. Body weights were determined on Day 0 (study initiation), Day 3 and Day 14 (study termination).
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weights, mortality

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 045 mg/kg bw

Based on:

test mat.

Remarks on result:

other: corresponding to 5 mL/kg bw based on a density of 1.009 g/cm³

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.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified