Octahydro-4,7-methano-1H-indenecarbaldehyde

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 May 1991 - 21 May 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Reliability 1 is assigned because the study conducted according to OECD TG 404 and in compliance with GLP, without deviations that influence the quality of the results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(1981)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Octahydro-4,7-methano-1H-indenecarbaldehyde

EC Number:

250-333-2

EC Name:

Octahydro-4,7-methano-1H-indenecarbaldehyde

Cas Number:

30772-79-3

Molecular formula:

C11H16O

IUPAC Name:

(1R,2S,3S,6R,7S)-tricyclo[5.2.1.0²,⁶]decane-3-carbaldehyde; bis((1R,2S,4R,6R,7S)-tricyclo[5.2.1.0²,⁶]decane-4-carbaldehyde)

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Formyltricyclodecan
- Storage condition of test material: at ambient air temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

- Source: Harald Schriever, Kaninchenfarm, Neuendamm 88, D-2740 Bremervörde
- Weight at study initiation: 2-3 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: Adjacent area of the untreated skin of each animal

Amount / concentration applied:

TEST MATERIAL
- Amount applied (volume): 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

5 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: dorsal, approximately 6 cm²
- Type of wrap if used: semi-occlusive dressing of Kosmoplast, held in place by non-irritating tape Elastoplast and Stülpa wrapped around the whole trunk of the animal.

REMOVAL OF TEST SUBSTANCE
- Washing: Residual samples were carefully washed off with water or an appropriate solvent
- Time after start of exposure: 4 hours

OBSERVATIONS
- Clinical signs for erythema and oedema: 30-60 min, 24 hours, 48 hours and 72 hours after patch removal and thereafter once daily up to day 5. Observations were extended to determine reversibility or irreversibility of the lesions.

SCORING SYSTEM
The irritation was assessed according to the numerical scoring system according to OECD 404 (1981).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24, 48 and 72 hours (mean)

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 4 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24, 48 and 72 hours (mean)

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 4 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24, 48 and 72 hours (mean)

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 4 days

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24, 48 and 72 hours (mean)

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 4 days

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24, 48 and 72 hours (mean)

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 4 days

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24, 48 and 72 hours (mean)

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 4 days

Irritant / corrosive response data:

Animals showed slight signs of erythema within 3 days after treatment. No signs of oedema were observed, apart from a very slight oedema in one animal up to 60 minutes after treatment. The observed findings were reversible within 4 days.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a skin irritation study with 3 rabbits, performed according to OECD guideline 404, the mean erythema and oedema scores for all animals were well below the limit mentioned in the EU classification criteria. Based on these results, the substance is not considered to be irritating to skin.

Executive summary:

The substance was tested in a skin irritation test in 3 rabbits in accordance with OECD TG 404 test guideline. The animals showed slight signs of erythema within 3 days after treatment. No signs of oedema were observed, apart from a very slight oedema in one animal up to 60 minutes after treatment. The observed findings were reversible within 4 days. The mean value for erythema and oedema from gradings at 24, 48 and 72 hours after patch removal was well below the limit mentioned in the EU classification criteria (which is 2.3). No corrosive effect was observed. The irritation was fully reversible within 4 days after treatment. Based on these results, the substance is not considered to be irritating to skin.