Tricyclodecanedimethanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Pre-guideline study comparable to guideline study with acceptable restrictions; 24 h occlusive application, no data on purity of test substance

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Principles of method if other than guideline:

Method: other: Federal Register 38, No. 187, 27.9.1973, p 27019. Method used is similar to OECD Guideline 404 (Acute Dermal Irritation/Corrosion) with some deviations (exposure period 24 h, occlusive application, no data on test substance purity, reading times slightly different: in OECD TG 404: readings to be performed 24, 48, and 72 h after patch removal (i.e. 28, 52, and 76 h after dermal administration); here readings performed 24, 48, and 72 h after dermal application).

GLP compliance:

no

Test material

Test material information

Constituent 1

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 TM
- Physical state: colorless viscous liquid
- Analytical purity: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

Test animals

Species:

rabbit

Strain:

other: SPF-Albino-Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 1.5 - 2 kg
- Housing: individually caged
- Diet (e.g. ad libitum): compound feeds ERKA 8300 from Robert Koch oHG, Hamm, Germany
- Water (e.g. ad libitum): yes
- Acclimation period: no dat

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): pure test substance

Duration of treatment / exposure:

24 hour(s)

Observation period:

up to 48 hrs after patch removal

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: test substance was applied on surgical gaze covered with occlusive PVC sheeting. The rump of the animal was wrapped with an elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 hrs

SCORING SYSTEM: Skin reactions were scored according to the table of OECD Guideline 404 (Draize).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48 h

Score:

0

Max. score:

0

Reversibility:

fully reversible within: 24 hrs after patch removal

Remarks on result:

other: slight erythema (grade 1) were observed only at patch removal (end of 24 h exposure period)

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal: #1, #2, #4, #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal: #2, #5

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Any other information on results incl. tables

Effects of the undiluted test substance on intact rabbit skin:

Slight irritation (erythema grade 1, no edema) was noted in 2 of 6 animals immediately after patch removal. No skin reaction was noted 24 and 48 hrs thereafter.

 

Animal	Skin reaction	After patch removal
		0 hrs	24 hrs	48 hrs
1	Erythema	0	0	0
	Edema	0	0	0
2	Erythema	1	0	0
	Edema	0	0	0
3	Erythema	0	0	0
	Edema	0	0	0
4	Erythema	0	0	0
	Edema	0	0	0
5	Erythema	1	0	0
	Edema	0	0	0
6	Erythema	0	0	0
	Edema	0	0	0

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Only transient, slight erythema, but no edema, was noted in 2/6 animals after 24 hr occluded contact to intact rabbit skin. The substance was not irritating to the rabbit skin, even under worst case conditions (occlusion, 24 hr-exposure period).

Executive summary:

In a primary dermal irritation study six Himalayan rabbits were dermally exposed to 0.5 mL of octahydro-4,7-methano-1H-indenedimethanol (TCD Alkohol DM undiluted) for 24 hours to an area of approx. 6 cm². Animals then were observed for additional 48 hours. Irritation was scored by the method of Draize.

After 24 hours occlusive exposure, only 2 of 6 animals showed slight erythema (grade 1). No edema were observed. 24 hours after patch removal, the erythema had subsided. In this study, octahydro-4,7-methano-1H-indenedimethanol (TCD Alkohol DM) is minimally irritating to the skin (Hollander/Hoechst AG, 1975b).

This dermal irritation study in the rabbit is acceptable. It complies with the OECD guideline 404 with reasonable restrictions. Deviations are rather expected to enhance the irritating effect.