1,4:5,8-Dimethanonaphthalene, 1,2,3,4,4a,5,8,8a-octahydro-, (1R,4S,4aR,5S,8R,8aS)-rel-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 March 2013 to 16 April 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: JMAFF, 12 Nousan No 8147, 2000

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Certificate from MHRA included in reports

Test type:

fixed dose procedure

Test material

Test material information

Constituent 1

Reference substance name:

(1R,2R,3S,6R,7S,8S)-tetracyclo[6.2.1.1³,⁶.0²,⁷]dodec-4-ene

EC Number:

700-678-4

Cas Number:

1076-12-6

Molecular formula:

C12H16

IUPAC Name:

(1R,2R,3S,6R,7S,8S)-tetracyclo[6.2.1.1³,⁶.0²,⁷]dodec-4-ene

Details on test material:

- Name of test material (as cited in study report): TCD

- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type: Organic
- Physical state: Clear Liquid
- Analytical purity: ca 100%


- Lot/batch No.: M0904
- Expiration date of the lot/batch: 31 December 2013



- Storage condition of test material: Refigerated in the dark

Test animals

Species:

rat

Strain:

other: CD (Hsd SD) albino rats

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 278-316 g for males and 181-198g for females

- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 50 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23 deg C
- Humidity (%): 40-70 %
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hrs/12 hrs

IN-LIFE DATES: From: 02 April 2013 To: 16 April 2013

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 50mm x 50mm
- % coverage: 10
- Type of wrap if used: porous gauze held in place with a non-irritating de=ressing and further covered with a waterproof dressing encircled around the trunk of the animal

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with weak detergent in warm water.
- Time after start of exposure: 24 hours

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

- For solids, paste formed: /no

Duration of exposure:

24 Hours

Doses:

2000 mg.kg bodyweight

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: frequent observations on day of dosing and twice per day until the end of the experimental period. Bodyweight recorded on Days 1, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, other: macroscopic pathology

Statistics:

mean body wieghts andweekly individual bodyweight changes recorded. No statistical analysis.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths during study

Clinical signs:

other: Slight to well-defined erythema was seen in two males (P1, P5) with very slight erythema noted in a further two males (P3, P4) and four females (P6, P8, P9, P10). These reactions had resolved by Day 6 for the males and Day 11 for the females. No dermal re

Gross pathology:

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

Other findings:

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

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

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