Alcohols C13-15 (branched and linear, odd numbered), reaction product with 1-chloro-2,3-epoxypropane

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:

from 20 september 1989 to 4 october 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: guideline test with GLP which is used for read-across purpose

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

HEXANE-DIOLDIGLYCIDYL-ETHER

IUPAC Name:

HEXANE-DIOLDIGLYCIDYL-ETHER

Constituent 2

Reference substance name:

1,6-bis(2,3-epoxypropoxy)hexane

EC Number:

240-260-4

EC Name:

1,6-bis(2,3-epoxypropoxy)hexane

Cas Number:

16096-31-4

Molecular formula:

C12H22O4

IUPAC Name:

2,2'-[hexane-1,6-diylbis(oxymethylene)]dioxirane

Constituent 3

Reference substance name:

1,6-bis(2,3-epoxypropoxy) hexane

IUPAC Name:

1,6-bis(2,3-epoxypropoxy) hexane

Test material form:

other: viscous liquid

Details on test material:

description: colourless viscous liquid
storage conditions: room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Bantin& Kingman Ltd.
- Age at study initiation: 10 - 14 weeks old
- Weight at study initiation: males: 216 - 244 g, females: 211 - 232 g
- Fasting period before study:
- Housing: in groups of five by sex in solid-floor polypropylene cages with sawdust bedding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:5 days

ENVIRONMENTAL CONDITIONS
- Temperature (21 - 23 °C):
- Humidity (54 - 67%):
- Air changes (per hr):15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hrs

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Approximately twenty-four hours prior to the commencement of the test the back and flanks of each animal were clipped free of hair using veterinary clippers to expose a skin area of approximately 5 cm x 4 cm.
A single group of animals was treated as follows:
DOSE LEVEL SPECIFIC DOSE VOLUME NUMBER OF RATS
mg/kg GRAVITY mL/kg MALE FEMALE
2000 1.039 1.93 5 5

Duration of exposure:

24 hrs

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

not required

Details on study design:

All animals were observed for overt signs of toxicity and death 1 and 4 hours after dosing and subsequently at least once daily for fourteen days. Individual bodyweights were recorded on the day of treatment (day 0) and on days seven and fourteen. All animals were subjected to a gross necropsy examination for any macro-scopic abnormalities. No tissues were retained.

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There is no death found in the study.

Clinical signs:

other: No signs of systemic toxicity or skin irritation were noted during the study.

Gross pathology:

No abnormalities were noted at necropsy of animals kilied at the end of the study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal median lethal dose (LD50) of the test material, HEXANE-DIOLDIGLYCIDYL-ETHER, in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg bodyweight.

Executive summary:

The study was designed to assess the acute dermal toxicity of the test material to the rat following a single, 24 hours, occluded application of the test material to intact skin for 24hrs, at a dose level of 2000 mg/kg bodyweight. The test was performed to comply with OECD guidelines of No.402. There were no deaths. No signs of systemic toxicity or skin irritation were noted during the study. All animals showed expected gain in bodyweight during the study. No abnormalities were noted at necropsy of animal's killed at the end of the study. The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg bw, which indicated that test materials shall not be classified in accordance with CLP (Regulation EC No. 1272/2008).