2,6-diethyl-p-toluidine

Endpoint summary

Description of key information

The test item was tested in a skin and eye irritation study on three NZW rabbits. Both studies were conducted in accordance with GLP and following OECD-guidelines. Only slight irritating effects were observed in the two studies, therefore the test item can was considered to be non-irritant to rabbit skin.

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:

December 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-compliant guideline study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna UK Ltd.).
- Sex: females
- Weight at study initiation: 2.2 up to 2.9 Kg
- Fasting period before study: none
- Housing: gang housing à 5 animals per cage and sex
- Diet (e.g. ad libitum): "ssniff K 4" from SSNIFF Spezialdiäten GmbH, Soest/Westfalen, Germany
- Amount of diet: ca. 100 to 120 g per animal and day, once daily
- Water (e.g. ad libitum): tap water
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 50%
- Air changes (per hr): 10 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours (artificial light)

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

500 ul

Duration of treatment / exposure:

24 hours

Observation period:

1, 24, 48, 72 hours and 7 days

Number of animals:

3 female rabbits

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24-72 hours

Score:

0.6

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24-72 hours

Score:

0

Max. score:

0

Irritant / corrosive response data:

Th test item showed slight erythema with max. score of 1 in all three animals 24 hours after treament. These effects were reversible within 48 hours in one animal and within 72 hours in the other two animals.

Other effects:

None

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item is not irritant to rabbit skin.

Executive summary:

The skin irritation study was conducted as GLP-study according to OECD no. 404. The test was performed on three NZW rabbits. Slight erythema were observed in all three animals with a mean score of 0.6. These effcts were found to be reversible within 72 hours. Oedema were not seen in all three rabbits. Therefore, the substance can be considered as non-irritant to rabbit 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:

December 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-compliant guideline study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Interfauna UK Ltd.).
- Sex: females
- Weight at study initiation: 2.2 up to 2.9 Kg
- Fasting period before study: none
- Housing: gang housing à 5 animals per cage and sex
- Diet (e.g. ad libitum): "ssniff K 4" from SSNIFF Spezialdiäten GmbH, Soest/Westfalen, Germany
- Amount of diet: ca. 100 to 120 g per animal and day, once daily
- Water (e.g. ad libitum): tap water
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 50%
- Air changes (per hr): 10 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours (artificial light)

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

500 ul

Duration of treatment / exposure:

4 hours

Observation period (in vivo):

24, 48 and 72 hours

Number of animals or in vitro replicates:

3 female rabbits

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24-72 hours

Score:

0.23

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24-72 hours

Score:

0

Max. score:

0

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24-72 hours

Score:

0.1

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24-72 hours

Score:

0

Max. score:

0

Irritant / corrosive response data:

One animal showed slight corneal opacity up to 48 hours after treatment. Redness of the conjunctiva was noted in two animals, being reversible within 48 hours.

Other effects:

None

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item is not irritant to rabbit skin.

Executive summary:

The eye irritation study was conducted as GLP-study according to OECD no. 405. The test was performed on three NZW rabbits. Slight corneal opacity and conjunctival redness were observed in to animals. These effcts were found to be reversible within 48 hours.

Therefore, the substance can be considered as non-irritant to the eyes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Key study: Skin irritation – in vivo

The skin irritation study was conducted as GLP-study according to OECD no. 404. The test was performed on three NZW rabbits. Slight erythema were observed in all three animals with a mean score of 0.6. These effcts were found to be reversible within 72 hours. Oedema were not seen in all three rabbits. Therefore, the substance can be considered as non-irritant to rabbit skin.

Key study: Eye irritation – in vivo

The eye irritation study was conducted as GLP-study according to OECD no. 405. The test was performed on three NZW rabbits. Slight corneal opacity and conjunctival redness were observed in to animals. These effcts were found to be reversible within 48 hours.

Therefore, the substance can be considered as non-irritant to the eyes.

Justification for selection of skin irritation / corrosion endpoint:
GLP study following OECD-guideline; Klimisch 1

Justification for selection of eye irritation endpoint:
GLP study following OECD-guideline; Klimisch 1

Justification for classification or non-classification

Based on the data available, the substance does not have to be classified and labelled according to Directive 67/548/EEC (DSD) or Regulation 1272/2008/EC (CLP).