2-hydroxyethyl palmitate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

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

Adequacy of study:

weight of evidence

Study period:

09 Dec - 27 Dec 1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP-Guideline study, tested with the source substance C8-C10-1,3-Butandiolester (CAS No. 853947-59-8). According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Justification for type of information:

The Glycol ester category covers esters of an aliphatic diol (ethylene glycol (EG), propylene glycol (PG) or 1,3-butyleneglycol (1,3-BG)) and one or two carboxylic fatty acid chains. The fatty acid chains comprise carbon chain lengths ranging from C6 to C18, mainly saturated but also mono unsaturated C16 and C18, branched C18 and epoxidized C18.
 
The available data allows for an accurate hazard and risk assessment of the category and the category concept is applied for the assessment of environmental fate and environmental and human health hazards. Thus, where applicable, environmental and human health effects are predicted from adequate and reliable data for source substance(s) within the group by interpolation to the target substances in the group (read-across approach) applying the group concept in accordance with Annex XI, Item 1.5, of Regulation (EC) No 1907/2006. In particular, for each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across.
A detailed justification for the grouping of chemicals and read-across is provided in the technical dossier (see IUCLID Section 13).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

853947-59-8

Cas Number:

853947-59-8

IUPAC Name:

853947-59-8

Details on test material:

- Name of test material (as cited in study report): trade name
- Chemical denomination: 1,3-Butanediol diester of a mixture of 60% n-octanoic acid and 40% n-decanoic acid
- ID number: 3630/81 334
- Batch number: 12430
- Physical state: odourless oily liquid
- Analytical purity: Butanediol dioctanoate: 36.3 (% by area), butanediol octanoate decanoate: 46.3 (% by area), butanediol didecanoate: 15.1 (% by area)
- Expiration date of the lot/batch: 06/1993
- Storage condition of test material: In a closed container in a laboratory hood.
- Other: pH: neutral; density (20 °C): 0.91 g/cm³

Test animals

Species:

rat

Strain:

other: Bor: WISW (SPF Cpb)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Weight at study initiation: 247 - 273 g (males) and 225 - 243 g (females)
- Housing: animals were housed individually in type III Makrolon cages
- Diet: Ssniff R 10 complete feed for rats (Ssniff Spezialfutter GmbH, Soest, Germany), ad libitum
- Water: drinking water (Gelsenwasser, Haltern, Germany), ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: clipped dorsal skin of the animals
- % coverage: 10%
- Type of wrap if used: The test material was covered with a mull patch and fixed with a semi-occlusive dressing and a strip of plaster.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw, 2.2 mL/kg bw

Duration of exposure:

24 h

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 and weighing: animals were weighed on the day of administration, on Day 7 and at the end of the study period (Day 14).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

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:

The necropsies at the end of the study revealed no macroscopic changes to organs, nor were there any abnormalities in the skin and subcutaneous tissue in the application area.

Other findings:

The animals showed no dermal reactions 24 h after administration and up to the end of the 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