Trichloro(N,N-dimethyloctylamine)boron

Endpoint summary

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:

October 1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP and Pre OECD study. Observation limited to 24 hours and 72 hours after treatement.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

24h application and only 24 and 72h observation.

Principles of method if other than guideline:

The test was carried out according to the method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965).

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

The rabbits were caged singly in an experimental room maintained at a temperature of 2D°C. (± 1°) and a relatiue humidity of 50-70%. Animals uere exposed to artificial light for 10 hours daily frorn 08.00 - 18.00 hours. A commercial irradiated diet (Styles-Oxoid) was fed ad lib. Sterile filtered water was evailable at all times.

Type of coverage:

occlusive

Preparation of test site:

other: Abraded skin/Intact skin

Vehicle:

other: 50% PEG

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 mL
- Concentration (if solution): 50%

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

3 males and 3 females

Details on study design:

TEST SITE
- Area of exposure:2.5 cm2
- Type of wrap if used: aluminium foil secured uith "Sleek"* adhesive taps. Ths test sites uere then couered by a 6" uide "Coban"** self adhesive bandage in order to retain the test substance in close contace uith the skin.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No


SCORING SYSTEM:
Erythema and Eschar Formation
Description Grads
No erythema O
Slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet red) to slight eschar formation 4

Oedema Formation
Description Grade
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined by definite raising) 2
Moderate oedema (raised approximately 1 mm.) 3
Seuere-oedema (raised more than 1 mm. and extending beyond the area of exposure) 4

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: Intact skin score presented here, 48 hour score not presented in the study report

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: Intact skin score presented here, 48 hour score not presented in the study report

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: Intact skin score presented here, 48 hour score not presented in the study report

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: Intact skin score presented here, 48 hour score not presented in the study report

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: Intact skin score presented here, 48 hour score not presented in the study report

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: Intact skin score presented here, 48 hour score not presented in the study report

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: Intact skin score presented here, 48 hour score not presented in the study report

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: Intact skin score presented here, 48 hour score not presented in the study report

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: Intact skin score presented here, 48 hour score not presented in the study report

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: Intact skin score presented here, 48 hour score not presented in the study report

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: Intact skin score presented here, 48 hour score not presented in the study report

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: Intact skin score presented here, 48 hour score not presented in the study report

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the study conditions, the test substance was found to be not irritating to rabbit skin.

Executive summary:

A study was conducted to assess the skin irritation potential of test substance, trichloro(N,N-dimethyloctylamine)boron in rabbits in a guideline similar to OECD Guideline 404. Six New Zealand White rabbits (3 males and 3 females) were treated during 24 hours under occlusive dressing with 1.0 mL of the substance’s solution (mixed with a 50% aqueous solution of PEG). After 24 hours slight erythema was seen on l/6(intact and abraded sites and very slight oedema on 1/6 intact and 2/6 abraded sites. After 72 hours, all sites were normal. Generally, there was no differences-seen in the reactions between intact and abraded sites. The primary irritation score was 0.2. Under the study conditions, the test substance was found to be not irritating to rabbit skin (Hess, 1976).

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:

October 1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Pre-OECD study, non-GLP

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

The rabbits were caged singly in an experimental room maintained at a temperature of 20°C. ( + 1°) and a relative humidity of 50-70%. Animals were exposed to artificial light for 10 hours daily from 08.00 - 18.00 hours. A commercial irradiated diet (Styles-Oxoid) was fed ad lib. Sterile filtered water was available at all times.

Vehicle:

unchanged (no vehicle)

Controls:

other: the right eye served as control

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

Single exposure (The eyelids were held closed for 1 second.)

Observation period (in vivo):

The rabbits were examined 1, 24, 48 and 72 hours after application cf the test compound

Number of animals or in vitro replicates:

3 males and 3 females

Details on study design:

The eyes of the experimental animals were examined and found normal prior to the test. 100mg of the test compound were instilled into the conjunctiual sac of the left eye. The eyelids were then held closed for 1 second. The right eye served as a control. After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with approximately 200 ml. of warm water.
The rabbits were examined 1, 24, 48 and 72 hours after application cf the test compound

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #4

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #5

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Irritant / corrosive response data:

Con.junctiva.
A very slight reaction was seen in 3/3 unwashed and 1/3 washed eyes. one hour after the application of the compound.
Only one washed eye was still showing a reaction at 24 hours, but this had returned to normal by 48 hours.

Cornea.
Slight opacity with damage to the surface epithelium was seen transiently at one hour only in one unwashed eye.
Generally, there was uery little difference seen in the reactions between washed and unwashed eyes.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the study conditions, the trichloro(N,N-dimethyloctylamine)boron was found to be not irritating to rabbit eyes.

Executive summary:

A study was conducted to assess the eye irritation potential of trichloro(N,N-dimethyloctylamine)boron in rabbits in a guideline similar to OECD Guideline 405 without GLP. Three male rabbits and three female rabbits New Zealand rabbits were used in the test. 100 mg of the test compound were instilled into the conjunctival sac of the left eye. The eyelids were then held closed for 1 second. The right eye served as a control. After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with approximately 200 mL of warm water. The rabbits were examined 1, 24, 48 and 72 hours after application of the test compound. A very slight reaction (redness of the conjunctivae) was seen in 3/3 unwashed and 1/3 washed eyes one hour after the application of the compound. Only one washed eye was still showing a reaction at 24 hours, but this had returned to normal by 48 hours. Slight corneal opacity with damage to the surface epithelium was seen transiently at one hour only in one unwashed eye. Under the study conditions, the trichloro(N,N-dimethyloctylamine)boron was found to be not irritating to rabbit eyes (Hess, 1976).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

A study was conducted to assess the skin irritation potential of test substance, trichloro(N,N-dimethyloctylamine)boron in rabbits in a guideline similar to OECD Guideline 404. Six New Zealand White rabbits (3 males and 3 females) were treated during 24 hours under occlusive dressing with 1.0 mL of the substance’s solution (mixed with a 50% aqueous solution of PEG). After 24 hours slight erythema was seen on l/6(intact and abraded sites and very slight oedema on 1/6 intact and 2/6 abraded sites. After 72 hours, all sites were normal. Generally, there was no differences-seen in the reactions between intact and abraded sites. The primary irritation score was 0.2. Under the study conditions, the test substance was found to be not irritating to rabbit skin (Hess, 1976).

Eye irritation

A study was conducted to assess the eye irritation potential of trichloro(N,N-dimethyloctylamine)boron in rabbits in a guideline similar to OECD Guideline 405 without GLP. Three male rabbits and three female rabbits New Zealand rabbits were used in the test. 100 mg of the test compound were instilled into the conjunctival sac of the left eye. The eyelids were then held closed for 1 second. The right eye served as a control. After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with approximately 200 mL of warm water. The rabbits were examined 1, 24, 48 and 72 hours after application of the test compound. A very slight reaction (redness of the conjunctivae) was seen in 3/3 unwashed and 1/3 washed eyes one hour after the application of the compound. Only one washed eye was still showing a reaction at 24 hours, but this had returned to normal by 48 hours. Slight corneal opacity with damage to the surface epithelium was seen transiently at one hour only in one unwashed eye. Under the study conditions, the trichloro(N,N-dimethyloctylamine)boron was found to be not irritating to rabbit eyes (Hess, 1976).

Justification for classification or non-classification

Based on the results of the in vivo skin and eye irritation studies, the substance does not need to be classified according to EU CLP regulation (EC) 1272/2008.