Cyclohexane-1,2,4-triyltris(ethylene)

Endpoint summary

Description of key information

The test substance 1,2,4 -Trivinylcyclohexane (TVCH) was tested for irritation to skin and eyes in in vivo tests in rabbits before guidelines and test methods for in vitro testing of these endpoints have been established.

Under the present test conditions, TVCH is irritiating to the skin of rabbits after application of 0.5 ml to a skin area of 6 cm2. Exposure period was 4 hours, covered by a gauze patch. The test substance is not irritating to the 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

Study period:

08-Jan-1985 to 22-Jan-1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Species:

rabbit

Strain:

other: Kleine weiße Russen, Chbb-SPF

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Species/Strain: Rabbit (Kleine weiße Russen), Chbb-SPF
- Source: Fa. Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.2 - 2.5 kg
- Housing: single housing
- Diet: K4 Alleindiät für Kaninchen, SSniff Spezialfutter GmbH, 4770 Soest, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 14 days befor the first test-substance application

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-1°C
- Humidity (%): 60 +/-5 %
- Air changes (per hr): 15fold
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.5 ml, undiluted

Duration of treatment / exposure:

4 hour(s)

Observation period:

14 days

Number of animals:

3 Males and 3 Females

Details on study design:

Application of 0.5 ml of undiluted test substance on a 6 cm2 shaved area of skin covered with a gauze patch. Removal of residual test substance after 4 hours using water. Evaluation of results 1 and 24 hours after removal of the patch, and after 6, 8, 10, 14 days.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

other: Trend to reversibility clearly conceivable at the end of the observation period of 14 days.

Remarks on result:

positive indication of irritation

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

other: Trend to reversibility clearly conceivable at the end of the observation period of 14 days.

Remarks on result:

positive indication of irritation

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

other: Trend to reversibility clearly conceivable at the end of the observation period of 14 days.

Remarks on result:

positive indication of irritation

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

other: Trend to reversibility clearly conceivable at the end of the observation period of 14 days.

Remarks on result:

positive indication of irritation

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

other: Trend to reversibility clearly conceivable at the end of the observation period of 14 days.

Remarks on result:

positive indication of irritation

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

other: Trend to reversibility clearly conceivable at the end of the observation period of 14 days.

Remarks on result:

positive indication of irritation

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

fully reversible within: 10 days

Remarks on result:

positive indication of irritation

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 10 days

Remarks on result:

positive indication of irritation

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 10 days

Remarks on result:

positive indication of irritation

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 10 days

Remarks on result:

positive indication of irritation

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 10 days

Remarks on result:

positive indication of irritation

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 10 days

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

The test substance is irritating to skin.

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The test substance is irritating to skin.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (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:

08-Jan-1985 to 11-Jan-1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Species:

rabbit

Strain:

other: kleine weiße Russen, Chbb-SPF

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Species/Strain: Rabbit (Kleine weiße Russen), Chbb-SPF
- Source: Fa. Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.2 - 2.5 kg
- Housing: single housing
- Diet: K4 Alleindiät für Kaninchen, SSniff Spezialfutter GmbH, 4770 Soest, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 14 days befor the first test-substance application

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-1°C
- Humidity (%): 60 +/-5 %
- Air changes (per hr): 15fold
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.1 ml, undiluted

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3 male / 3 female

Details on study design:

Undiluted test substance (0.1 ml) was placed in the conjunctival sac of one eye, the other served as control. Test substance was not removed. Evaluation of results 1, 24, 48 and 72 hours after instillation of the test substance.

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:

0.3

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Following the instillation of the test substance into the rabbit eye no effects on cornea and iris were observed. In all 6 test animals the conjunctivae was reddened one hour after instiillation and a slight swelling and discharge were observed. After 24 hours, only a slight reddening could still be observed in 3 animals. All findings were resolved after 48 hours.

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance is not irritating to the eye. Thus, according to Regulation (EC) 1272/2008 the data are conclusive but not sufficient for classification.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The test substance has been shown to be irritating to skin but not to the eye in in vivo rabbit studies. Thus, classification for skin irritation category 2 is warranted.