Reaction mass of 1,2,3,4,5,6,7,8-octahydro-5,5-dimethylnaphthalene-2-carbaldehyde and 1,2,3,4,5,6,7,8-octahydro-8,8-dimethyl-2-naphthaldehyde

Endpoint summary

Description of key information

The test substance is not irritating to skin or eye.

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Specific details on test material used for the study:

- Description: Clear, transparent liquid

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: ENKI—Konijnenfarm, Someren, the Netherlands
- Weight at study initiation: 2500-3500 g
- Housing: individually in suspended, galvanized cages, fitted with wire-mesh floor and front
- Diet: Standard laboratory rabbit diet, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±3
- Humidity (%): 40-70
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

21 days

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: One day prior to the start of the experiment, the hair was removed from the back and flanks of the animals using electric clippers in a way as to avoid abrasions
- Type of wrap if used: Surgical patch measuring 1 inch x I inch. The patches were fixed to the application site by means of adhesive tape and the entire trunk of the rabbits was wrapped with an impervious material.

REMOVAL OF TEST SUBSTANCE
- Washing: no

OBSERVATION TIME POINTS
- Immediately after removal of the test substance and 24, 48, and 72 hours later

SCORING SYSTEM:
- By the method of Draize (J. Pharmacol. exptle Therape 82 (1944) 377—390).

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

not fully reversible within: 3 weeks

Irritation parameter:

erythema score

Basis:

animal: #2, #6

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 3 weeks

Irritation parameter:

erythema score

Basis:

animal: #3, #4

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 3 weeks

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

edema score

Basis:

animal: #1, #4

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 3 weeks

Irritation parameter:

edema score

Basis:

animal: #2, #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 3 weeks

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 3 weeks

Irritant / corrosive response data:

After three weeks only very slight erythema and slight scaliness were still observed in one rabbit.

Interpretation of results:

GHS criteria not met

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Specific details on test material used for the study:

- Description: Clear, transparant liquid

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: ENKI-Konijnenfarm, Someren, The Netherlands
- Weight at study initiation: 2500 - 3500 g
- Housing: Individually in suspended, galvanized cages, fitted with wire-mesh floor and front
- Diet: Standard laboratory rabbit diet, ad libitum
- Water: Tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±3
- Humidity (%): 40-70
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

other: The other untreated eye

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3 males

Details on study design:

The eyes of the rabbits were examined 24 hours prior to testing and only those animals without observable eye defects were used. 0.1 mL of the undiluted test material was allowed to fall on the everted lower lid of one eye of each rabbit; the upper and lower lid were then carefully closed and subsequently held together for about 1 second. The eyes were not washed out following administration. Ocular reactions were judged using the scoring scale from OECD guideline 405. Eye effects were examined 1 hour, 24, 48, and 72 hours.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

conjunctivae score

Basis:

animal: #2, #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

In a GLP-compliant skin irritation study, performed in accordance with OECD Guideline 404, six New Zealand rabbits were exposed to the test substance. 0.5 mL undiluted test substance was applied under occlusive conditions on the intact skin of the rabbits for 4 hours. Immediately after removal of the patch and test substance, and 24, 48, and 72 hours later, erythema and edema were scored according to Draize. After 24 -72 hours the dermal effects observed generally consisted of very slight or slight erythema with or without very slight edema. After three weeks only very slight erythema and slight scaliness were still observed in one rabbit. All other skin effects had cleared completely. Based on the results obtained and considering the worst-case approach used by the researchers (under occlusive conditions and no washing), it can be concluded that the test substance is not irritating to the skin.

Eye irritation

In a GLP-compliant eye irritation study, performed in accordance with OECD Guideline 405, three New Zealand rabbits were exposed to the test substance. 0.1 mL undiluted test substance was inserted in one eye of each rabbit. To prevent loss of test material, the eyes of the rabbits were carefully closed for 1 second. After 1, 24, 48, and 72 hours, the eyes were judged based on the scoring system described in the OECD guideline. The test substance only caused slight redness and swelling of the conjunctivae. After 72 hours these effects had cleared completely. Based on the results, it can be concluded that the test substance is not an eye irritant

Justification for classification or non-classification

The test substance does not have to be classified for skin or eye irritation according to Regulation (EC) No 1272/2008.