3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate, oligomers, reaction products with 2-butanone oxime

Endpoint summary

Description of key information

skin irritation, rabbit: not irritating
eye irritation, rabbit: slightly irritating
With regard to local effects in the respiratory tract the substance is classified for repeated toxicity with STOT RE 1 (see chapter 'Repeated Dose Toxicity’).

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:

other: GLP guideline 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)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- SPF Quality
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: at least 6 weeks old; weights between 1.0 and 3.5 kg
- sex: males

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: solid was moistened with 0.3 mL water

Controls:

other: surrounding untreated skin area of test animals served as control

Amount / concentration applied:

Amount: 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48, and 72 hours after application

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: approx. 6 cm²
- Type of wrap if used: non irritating tape

REMOVAL OF TEST SUBSTANCE
- 4 hours after application the dressing was removed and the skin cleaned of residual test substance using water

SCORING SYSTEM: Draize

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Other effects:

There were no systemic intolerance reactions.

Interpretation of results:

GHS criteria not met

Conclusions:

Classification: not irritating

Executive summary:

In a study performed according to OECD 404 the test item was shown to be not irritating to rabbit's skin. No systemic intolerance reactions were observed.

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:

other: GLP guideline 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)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Sex: female
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: at least 6 weeks old; body weights were between 1.0 and 3.5 kg

Vehicle:

unchanged (no vehicle)

Controls:

other: one untreated eye of test animals served as control

Amount / concentration applied:

The test item was gound to a powder using a mortar and pestle prior to weighing.
Amount: about 60.9 mg (according to about 0.1 mL)

Duration of treatment / exposure:

single treatment; the lid was held together for about one second after instillation

Observation period (in vivo):

24 hours after administration the eyes were treated with fluorescein and examined

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: none

SCORING SYSTEM: Draize

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #3

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 within: 48 h

Remarks:

(score 1 at 24 h)

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks:

(score 1 at 24 h)

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks:

(score 1 at 24 h)

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks:

(score 1 at 24 h)

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Other effects:

There were no systemic intolerance reactions.

Interpretation of results:

GHS criteria not met

Conclusions:

Classification: not irritating

Executive summary:

In a study performed according to OECD 405 the solid test item led to slight effects to the eyes of rabbits (redness grade 1 in all 3 animals and chemosis grade 1 in 1 animal) 24 hours after treatment. The effects disappeared 24 hours later. 1 hour after instillation remnants of the test substance and eye effects were observed.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

In a study performed according to OECD 404 the test item was shown to be not irritating to rabbit's skin. No systemic intolerance reactions were observed.

In a study performed according to OECD 405 the solid test item led to slight effects to the eyes of rabbits (redness grade 1 in all 3 animals and chemosis grade 1 in 1 animal) 24 hours after treatment. The effects disappeared 24 hours later. 1 hour after instillation remnants of the test substance and eye effects were observed.

With regard to local effects in the respiratory tract the substance is classified for repeated toxicity with STOT RE 1 (see chapter 'Repeated Dose Toxicity’).

Justification for classification or non-classification

The substance is not irritating to skin (Notox, 2001b) and only slightly irritating to eyes (Notox, 2001c), results that do not meet criteria according to EC Regulation 1272/2008 to be classified.

With regard to local effects in the respiratory tract the substance is classified for repeated toxicity with STOT RE 1 (see chapter 'Repeated Dose Toxicity').