Glycerides, C14-18

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

March 12th, 1985 - March 26th, 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP - guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: 79/831/EWG, Annex V, Part B

Deviations:

yes

Remarks:

analytical purity of test substance not given

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Glycerides, C16-18 and C18-hydroxy mono- and di-

EC Number:

295-191-2

EC Name:

Glycerides, C16-18 and C18-hydroxy mono- and di-

Cas Number:

91845-19-1

IUPAC Name:

91845-19-1

Details on test material:

- Name of test material (as cited in study report): Glycerides, C16-18 and C18-hydroxy mono- and di-
- Batch No.: 4026-3
- Physical state: pellets
- 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: Winkelmann GmbH, Borchen, Germany
- Age at study initiation: young adult
- Weight at study initiation: average weights: males: 179 g, females: 143
- Fasting period before study: no data
- Housing: individually in Makrolon cages type II with soft wood bedding
- Diet (e.g. ad libitum): Altromin 1324, Lage, Germany.
- Water (e.g. ad libitum): tap water
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 51
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: March 12th, 1985 - March 26th, 1985

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsum
- % coverage: 6 cm x 4 cm
- Type of wrap if used: gauze, polyethylen foil, leukosilk bandage and acrylastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 h

Duration of exposure:

24 hours

Doses:

2000 mg/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: several times on day of application, thereafter twice a day
- Frequency of observations and weighing: before administration and on days 2, 7 and 14.
- Necropsy of survivors performed: yes, after 14 days from all treated animals
- Other examinations performed: daily skin examination

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: rat

Mortality:

None.

Clinical signs:

other: No signs of systemic toxicity were observed.

Gross pathology:

No abnormalities observed.

Other findings:

No local skin irritation observed.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU