1,4:5,8-Dimethanonaphthalene, 2-ethylidene-1,2,3,4,4a,5,8,8a-octahydro-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 October 2010 - 04 November 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to official EC, OECD, and EPA test guidelines, and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Remarks:

The study report includes a Certificate of GLP Compliance for the testing laboratory, issued by the MHRA.

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

ETD

IUPAC Name:

ETD

Details on test material:

- Name of test material (as cited in study report):ETD (Chemical name: ETD (Ed-TCD))
- Substance type: organic
- Physical state: Transparent liquid
- Analytical purity: c.a. 100%
- Lot/batch No.: M0901
- Expiration date of the lot/batch: End of December 2011
- Storage condition of test material: in dark, refrigerated (c.a. 4°C)

Test animals

Species:

rat

Strain:

other: Crl:CD 'SD'

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: UK
- Age at study initiation: approximately eight to twelve weeks
- Weight at study initiation: 217-374 g
- Fasting period before study: no
- Housing: Animals were housed inside a barriered rodent facility. The animal room was kept at positive pressure with respect to the outside by its own supply of filtered fresh air, which was passed to atmosphere and not re-circulated.
- Diet (e.g. ad libitum): standard rodent diet (Rat and Mouse No. 1 Maintenance Diet)
- Water (e.g. ad libitum): potable water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):19-23°C
- Humidity (%):40-70
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours continuous dark per 24 hours

IN-LIFE DATES: From: 14 October 2010 To: 04 November 2010

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

not specified

Details on dermal exposure:

TEST SITE
- Area of exposure: 50mm x 50mm
- % coverage:10% of the total body surface area
- Type of wrap if used: The treatment area was covered with porous gauze held in place with a non-irritating dressing, and further covered by a waterproof dressing encircled firmly around the trunk of the animal.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000mg/kg bodyweight

Duration of exposure:

24 hrs

Doses:

2000 mg/kg bodyweight (1.98 mL/kg bodyweight)

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: The weight of each animal was recorded on Day 1 (prior to dosing), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, local dermal irritation (assessed in terms of erythema / eschar formation, and oedema formation).
Individual weekly bodyweight changes and group mean bodyweights were calculated.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: Clinical signs of reaction of treatment were confined to reddening of the extremities, seen in all animals (E1-E10). This sign was first noted on Day 1 (within approximately one hour of dosing) and recovery, as judged by external appearance and behaviour,

Gross pathology:

No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute median lethal dermal dose (LD50) to rats of ETD was demonstrated to be greater than 2000 mg/kg bodyweight.