Trichloro(N,N-dimethyloctylamine)boron

Skin irritation / corrosion

Administrative data

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.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

Trichloro(N,N-dimethyloctylamine)boron

EC Number:

252-200-4

EC Name:

Trichloro(N,N-dimethyloctylamine)boron

Cas Number:

34762-90-8

Molecular formula:

C10H23BCl3N

IUPAC Name:

dimethyl(octyl)(trichloro-λ⁵-boranylidene)amine

Test material form:

other: off white waxy solid

Details on test material:

Name TK 12146
ZK 502
3942
Batch : Op1/76 K-650

Test animals

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.

Test system

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

Results and discussion

In vivo

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

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

Results 6

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

Results 7

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

Results 8

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

Results 9

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

Results 10

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

Results 11

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

Results 12

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

Applicant's summary and conclusion

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).