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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 11 DEC 1980 to 2 JAN 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
; occlusive wrapping, individual housing only during exposure
Principles of method if other than guideline:
The study is a pre-guideline study following the method of Noakes and Sanderson (Brit. J. Indust. Med. 1969, 26, 59-64). The method used is similar to OECD Guideline 402 (Acute Dermal Toxicity).
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tricyclodecanedimethanol
EC Number:
248-096-5
EC Name:
Tricyclodecanedimethanol
Cas Number:
26896-48-0
Molecular formula:
C12H20O2
IUPAC Name:
[3-(hydroxymethyl)tricyclo[5.2.1.0²,⁶]decan-8-yl]methanol
Details on test material:
- Name of test material (as cited in study report): TCD - Alkohol DM
- Physical state: viscous liquid
- Analytical purity: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Tuck and Sons Limited, Battlesbridge, Essex, England
- Age at study initiation: no data
- Weight at study initiation: 171 - 237 g
- Fasting period before study: yes
- Housing: individually during the 24 hour exposure period, and then in groups of up to 5 animals; solid floor polypropylene cages furnished with softwood sawdust
- Diet (e.g. ad libitum): rat diet, Nottingham University, Sutton Bonington, Leicestershire, England
- Water (e.g. ad libitum): yes
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 3°C
- Humidity (%): no data
- Air changes (per hr): 20
- Photoperiod (hrs dark / hrs light): 10 /14

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 6 x 10 cm, dorsal and lateral
- % coverage: no data
- Type of wrap if used: aluminium foil thinly covered with test substance hold in place by encircling the trunk of the animal with a strip of elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): sponging with detergent and warm water followed by rinsing with water and drying
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mL/kg
- Concentration (if solution): pure test substance
Duration of exposure:
24 h
Doses:
10000 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: observation at 0.5, 1 and 4 hours following treatment and then once daily for 14 days, weighing at day 0 and day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
10 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: None of the animals died during the 14 days observation period.
Mortality:
None of the treated animals (5 males and 5 females) died.
Clinical signs:
other: All animals exhibited subdued activity up to 4 hours after treatment.
Gross pathology:
No abnormal macroscopic lesions were observed in any of the test animals.
Other findings:
The dermal application caused no irritation and no changes were noted at the terminal examination at 14 days post application.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal toxicity was determined to be > 10000 mg/kg bw. Thus the acute dermal toxicity is very low. No classification is required according to EU legislation.
Executive summary:

In an acute dermal toxicity study, 5 male and 5 female adult Sprague-Dawley rats were dermally exposed to octahydro-4,7 -methano-1H-indenedimethanol (TCD-Alkohol DM) for 24 hours at a single dose of 10000 mg/kg bw.  The exposed area was about 6 x 10 cm. Animals were observed for 14 days.

No mortality was observed.

Thus the dermal LD50 is > 10000 mg/kg bw (LD0 = 10000 mg/kg bw; Collier/Safepharm, 1981a).

Octahydro-4,7 -methano-1H-indenedimethanol (TCD-Alkohol DM) is of low dermal toxicity based on the observed LD50 value.

This acute dermal toxicity study in the rat is acceptable. It complies with the OECD guideline 402