1,6-dichlorohexane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-05-07 to 2012-10-12

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study OECD and EU guidelines were followed

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted February 24, 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Version / remarks:

dated August 1998

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

dated May 31, 2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,6-dichlorohexane

EC Number:

218-491-7

EC Name:

1,6-dichlorohexane

Cas Number:

2163-00-0

Molecular formula:

C6H12Cl2

IUPAC Name:

1,6-dichlorohexane

Test material form:

other: liquid

Test animals

Species:

rat

Strain:

other: CD/Crl:CD (SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Males: approx. 8 weeks; Females: approx. 9 weeks
- Weight at study initiation: Males: 218 - 232 g; Females: 201 - 221 g
- Fasting period before study: 16 hours before administration
- Housing: singly in MAKROLON cages (type III plus)
- Diet (e.g. ad libitum): ssniff® R/M-H V1534
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 55% ± 15%
- Photoperiod (hrs dark / hrs light): 12 hours

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 5 cm x 6 cm
- % coverage: approx. 1/10 of body surface
- Type of wrap if used: The test item was held in contact with the skin with 8 layers of gauze. The gauze was covered with a plastic sheet and secured with adhesive plaster strips on the application site for 24 hours.

TEST MATERIAL
- Amount(s) applied: 1.87 mL/kg b.w.

Duration of exposure:

24 hours

Doses:

2000 mg/kg b.w.

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: 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration (observation); body weight: day 0, 8, 15, at necropsy; mortality: once daily
- 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 influence on animal behaviour or premature death was noted.

Clinical signs:

other: No skin reactions were observed at the application site. The macroscopic examination did not reveal any changes.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The LD50 (male/female) was greater than 2000 mg/kg b.w. after 24 hours and 14 days.