Heptanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol pentanoate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

19 June 1996 to 5 July 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study conducted according to OECD Guideline with restrictions.

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 402 (Acute Dermal Toxicity)

Deviations:

yes

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate

EC Number:

234-392-1

EC Name:

Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate

Cas Number:

11138-60-6

IUPAC Name:

2,2-bis[(octanoyloxy)methyl]butyl decanoate

Test material form:

other: liquid

Details on test material:

- Physical state: Yellow liquid
- Lot/batch No.: 96012
- Expiration date of the lot/batch: 01.01.2006
- Storage condition of test material: RT
- Analytical purity: Neat

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HRP, Pennsylvania
- Age at study initiation: Young adults (at least 8 weeks)
- Weight at study initiation: males: 2.4-3.1 kg, females 2.5-2.7 kg
- Housing: Individually housed in suspended, stainless steel cages with wire mesh bottoms
- Diet (e.g. ad libitum): Lab Rabbit Diet HF, No 5326, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: males 58 d, females 60 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-21
- Humidity (%): 40-60
- 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: 12 cm x 14 cm, clipped area of the dorsal trunk surface
- % coverage: approx. 10% of body surface
- Type of wrap if used: Gauze secured with tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiping with distilled water
- Time after start of exposure: 24 h

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: mortality: twice daily; dermal observations: 1, 24, 48 and 72 h after bandage removal; observations of pharmacologic and toxicologic signs: 1, 2 and 4 h after dosing and daily thereafter for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: check of clinical signs and body weight

Statistics:

Not required

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality

Clinical signs:

other: No adverse effects observed

Gross pathology:

No adverse effects observed

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an acute dermal toxicity study in rats, the LD50 for read-across substance, decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate was > 2000 mg/kg bw.