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

Endpoint summary

Description of key information

Skin irritation (OECD TG 404): Not irritating
Eye irritation and severe damage (OECD TG 405): Not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(1981)

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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

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).

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

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

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

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

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye 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.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(1981)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

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

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

Vehicle:

unchanged (no vehicle)

Controls:

other: contralateral eye of test animals

Amount / concentration applied:

TEST MATERIAL
Amount applied (volume): 0.1 mL

Duration of treatment / exposure:

Single exposure

Observation period (in vivo):

5 days

Number of animals or in vitro replicates:

3

Details on study design:

TREATMENT
The test substance was introduced into the conjunctival sac of the left eye of each animal.

REMOVAL OF TEST SUBSTANCE
- Washing: no

OBSERVATIONS
The eyes of each animal were assessed for ocular reactions 1, 24, 48 and 72 hours after treatment and thereafter once daily up to day 5. Irritation scores and a description of all other (local) effects were recorded.

SCORING SYSTEM
The irritation was assessed according to OECD 405 (1981).

Irritation parameter:

cornea opacity score

Remarks:

(opacity)

Basis:

animal #1

Time point:

other: 24, 48 and 72 hrs (mean)

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 4 days

Irritation parameter:

cornea opacity score

Remarks:

(opacity)

Basis:

animal #2

Time point:

other: 24, 48 and 72 hrs (mean)

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 4 days

Irritation parameter:

cornea opacity score

Remarks:

(opacity)

Basis:

animal #3

Time point:

other: 24, 48 and 72 hrs (mean)

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 4 days

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Time point:

other: 24, 48 and 72 hrs (mean)

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 4 days

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Time point:

other: 24, 48 and 72 hrs (mean)

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 4 days

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Time point:

other: 24, 48 and 72 hrs (mean)

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 4 days

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24, 48 and 72 hrs (mean)

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 4 days

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 24, 48 and 72 hrs (mean)

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 4 days

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: 24, 48 and 72 hrs (mean)

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 4 days

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24, 48 and 72 hrs (mean)

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 4 days

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24, 48 and 72 hrs (mean)

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 4 days

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 24, 48 and 72 hrs (mean)

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 4 days

Irritant / corrosive response data:

Slight ocular secretion was observed in all animals 1 hour after treatment. In one animal slight alteration of the iris occurred after 1 hour of initiation. Up to 3 days after treatment redness and chemosis of the conjunctivae were observed in all animals. The effects were fully reversible within 4 days.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an eye irritation study with rabbits, performed according to OECD 405, the mean cornea, iris, conjunctivae redness and conjunctivae chemosis scores for all animals were below the limits mentioned in the EU classification criteria. Based on these results, the substance is not considered to be irritating to the eye.

Executive summary:

The substance was tested in an eye irritation test in 3 rabbits in accordance with OECD TG 405 test guideline. Slight ocular secretion was observed in all animals 1 hour after treatment. In one animal slight alteration of the iris occurred after 1 hour of initiation. Up to 3 days after treatment redness and chemosis of the conjunctivae were observed in all animals. The effects were fully reversible within 4 days. The mean cornea, iris, conjunctivae redness and conjunctivae chemosis scores of the 24, 48 and 72 hours reading for all animals were below the limits mentioned in the EU classification criteria (limits being 1, 1, 2 and 2, respectively). Based on these results, the substance is not considered to be irritating to the eye.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

In vivo skin irritation

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 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.

In vivo eye irritation

The substance was tested in an eye irritation test in 3 rabbits in accordance with OECD TG 405 test guideline. Slight ocular secretion was observed in all animals 1 hour after treatment. In one animal slight alteration of the iris occurred after 1 hour of initiation. Up to 3 days after treatment redness and chemosis of the conjunctivae were observed in all animals. The effects were fully reversible within 4 days. The mean cornea, iris, conjunctivae redness and conjunctivae chemosis scores of the 24, 48 and 72 hours reading for all animals were below the limits mentioned in the EU classification criteria (limits being 1, 1, 2 and 2, respectively). Based on these results, the substance is not considered to be irritating to the eye.

Justification for selection of skin irritation / corrosion endpoint:
The result of the study is reliable and adequate for covering the endpoint.

Justification for selection of eye irritation endpoint:
The result of the study is reliable and adequate for covering the endpoint.

Justification for classification or non-classification

According to the criteria outlined in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP), the substance does not to be classified as skin and eye irritant.