Diamminediisocyanatozinc

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

until 1986-01-02

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

with sufficient documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

OECD Guideline for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion".

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Annex V E.E.C. directive 79/831/EEC. Part B: Methods for the determination of toxicity. B4. Skin irritation

Deviations:

not specified

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Diamminediisocyanatozinc

EC Number:

401-610-3

EC Name:

Diamminediisocyanatozinc

Cas Number:

122012-52-6

Molecular formula:

C2H6N4O2Zn

IUPAC Name:

copper(2+) bis(carbonylazanide) diamine

Test material form:

solid: particulate/powder

Remarks:

white powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Froxfield Rabbits, Petersfield, Hampshire
- Age at study initiation: 9 to 12 weeks
- Weight at study initiation: 2.0 to 2.7 kg
- Housing: The rabbits were individually housed in metal cages with perforated floors.
- Diet (e.g. ad libitum): SDS Standard Rabbit Diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: The rabbits selected for the study were all acclimated to the laboratory environment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Animal room temperature was maintained at approximately 19°C
- Humidity (%): Relative humidity was maintained at 30-70%.
- Air changes (per hr): Air exchange was maintained at approximately 19 air changes per hour.
- Photoperiod (hrs dark / hrs light): Lighting was controlled by means of a time switch to give 12 hours of artificial light (0700-1900 hours) in each 24 hour period.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): neat

Duration of treatment / exposure:

4 h

Observation period:

Examination of the treated skin was made on Day 1 (i.e. approximately 30 minutes after removal of the patches) and on Days 2, 3 and 4.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: Approximately 24 hours prior to application of the test substance, hair was removed with electric clippers from the dorso-lumbar region of each rabbit exposing an area of skin approximately 10 cm square.
A 0.5 g amount of the test item was applied under a 2.5 cm square gauze pad to one intact skin site on each animal.
- Type of wrap if used: 2.5 cm square gauze pad; Each treatment site was occluded with "Elastoplast" elastic adhesive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed using distilled water to remove any residual test substance.
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
Examination of the treated skin was made on Day 1 (i.e. approximately 30 minutes after removal of the patches) and on Days 2, 3 and 4.

SCORING SYSTEM: according to the guideline, i.e.
Grading and scoring of the dermal reactions were performed using the prescribed numerical scoring system as follows:
Erythema and eschar formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3 Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Oedema formation:
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 millimeter) 3
Severe oedema (raised more than 1 millimeter 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

Max. score:

0

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

None of the animals showed any observable response to treatment throughout the observation period.

Any other information on results incl. tables

Dermal reactions elicited by the test item

Rabbit Number and Sex	E = Erythema 0 = Oedema	Day
		1*	2	3	4
439M	E 0	0 0	0 0	0 0	0 0
440F	E 0	0 0	0 0	0 0	0 0
441M	E 0	0 0	0 0	0 0	0 0

*Approximately 30 minutes after removal of the dressing M = Male  F = Female

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Given data allows the conclusion that the test was well performed acc. OECD TG 404 and that the results are reliable. The scoring data was gained according to OECD TG 404, which allows a proper classification. Both edema and erythema scores were in all three animal zero, so classification as skin irritant is not required under GHS.

Executive summary:

The study was performed acc. OECD TG 404 on 3 New Zealand white rabbits. 0.5 g of the test item was applied neat for 4 h under a semi-occlusive coverage on the clipped skin. After washing, scoring was performed as inidcated in the guideline. Application of the test item to rabbit skin for four hours under a semi- occlusive patch produced no observable skin irritation. Both edema and erythema scores were in all three animal zero, so classification as skin irritant is not required under Regulation 1272/2008.