Fatty acids, tall-oil, esters with ethylene glycol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 Oct - 11 Dec 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Analytical purity of test substance not specified and occlusive dressing according to former guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

not specified

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted in 2017

Deviations:

yes

Remarks:

analytical purity of test substance not specified and occlusive dressing according to former guideline, no rationale for in vivo testing

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Cas Number:

151661-88-0

Test material form:

solid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Züchter Winkelmann, Borchen, Germany
- Weight at study initiation: 251 g (males), 219 g (females)
- Housing: individually housed in Makrolon 2 cages and softwood bedding (Weichholzgranulat, ARWI-Center, Essen, Germany)
- Diet: Altromin-Haltungsdiät 1324 (Fa. Altromin GmbH, Lage, Germany), ad libitum.
- Water: tap water, ad libitum
- Acclimation period: 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-60
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: the undiluted test substance was moistened with water on the dressing

Details on dermal exposure:

TEST SITE
- Area of exposure: 6.5 cm x 4 cm clipped skin of the dorsal area of the trunk
- Type of wrap if used: The test material was held in contact with the skin with an adhesive bandage (Hansapor steril, Nr. 2275, Beiersdorf, Germany) and held in place with a 8 cm x 6 cm film (Applica, Nr. 1218, Beiersdorf, Germany) and an adhesive tape (Fixomull stretch, Nr. 2292, Beiersdorf, Germany).

REMOVAL OF TEST SUBSTANCE
- Residual test material was removed (no further details)
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- For solids, paste formed: yes, the undiluted test substance was moistened with water

Duration of exposure:

24 hours

Doses:

2000 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: symptoms and mortality were observed several times on the application day and afterwards twice daily. Body weights were observed on the day of application and 48 h, 7 and 14 days after application.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Remarks:

rat

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

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.

Other findings:

No local skin effects after exposure up to the end of the 14-day observation period seen.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.