N-nitro-N-(3-methyl-3,6-dihydro-2H-1,3,5-oxadiazin-4-yl)amine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1995-08-18 until 1995-11-20

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline-conform study under GLP without deviations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

431-060-1

EC Name:

-

Cas Number:

153719-38-1

Molecular formula:

Hill formula: C4H8N4O3 CAS formula: C4H8N4O3

IUPAC Name:

3-methyl-N-nitro-3,6-dihydro-2H-1,3,5-oxadiazin-4-amine

Details on test material:

- Name of test material (as cited in study report): CA 2343 A (Intermediate of CGA 293343)
- Substance type: mono-constituent organic substance
- Physical state: solid, fine, white powder
- Analytical purity: 96.7 %
- Impurities (identity and concentrations): no data
- Purity test date: no data
- Lot/batch No.: P.503005
- Expiration date of the lot/batch: Date of reanalysis: December 1996
- Stability under test conditions: not reported
- Storage condition of test material: 0 - 5 °C

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, Biberach, Germany
- Age at study initiation: 2 - 3 months
- Weight at study initiation: 2700 to 2970 g
- Housing: The animals were housed individually in metal cages
- Diet (e.g. ad libitum): The rabbits received ad libitum standard rabbit pellet - NAFAG 814, NAFAG, Gossau/SG, Switzerland
- Water (e.g. ad libitum): fresh water ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C,
- Humidity (%): 30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day


IN-LIFE DATES: From: 1995-08-22 To: 1995-08-29

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: 0,5 % Carboxymethylcellulose in 0,1 % wässrigem Polysorbat 80.

Controls:

yes, concurrent vehicle

Amount / concentration applied:

500 mg per patch

Duration of treatment / exposure:

4 h

Observation period:

7 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: approx. 6 cm²
- % coverage: A skin area of at least 36 cm2 was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (approx. 12-16 cm2) bearing 0.5 g of the test article was applied to the right flank of each animal. The skin area exposed directly to the test article was approx. 6 cm2. Weight of the rabbits 2700 to 2970 g.
- Type of wrap if used: The patches were loosely covered with an aluminum foil (approx. 36 cm2) and held in place for 4 hours by an adhesive tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): not applicable
- Time after start of exposure:


SCORING SYSTEM: OECD scoring system (documentd in the appendix of the original study report)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animals 1, 2, and 3

Time point:

other: 1 h

Score:

>= 0 - <= 1

Max. score:

1

Reversibility:

fully reversible within: 7 d

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

animals 1, 2, and 3

Time point:

other: mean of 24, 48 and 72 h

Score:

>= 0 - <= 0.33

Max. score:

1

Reversibility:

fully reversible within: 7 d

Irritant / corrosive response data:

Erythema and edema score max. 1 at individual animals. Reversibility of any observed effect within 7 days

Other effects:

None reported

Any other information on results incl. tables

Tab. 1: Individual Skin Reaction Scores

	Erythema			Edema
Animal no.	1CF/TF	2 CF/TF	3CF/TF	1 CF/TF	2 CF/TF	3 CF/TF
after 1 h	0/1	0/1	0/1	0/1	0/0	0/1
after 24 h	0/0	0/1	0/1	0/0	0/0	0/1
after 48 h	0/0	0/0	0/1	0/0	0/0	0/0
after 72 h	FD	0/0	0/1	FD	0/0	0/0
mean 24-72 h	0 / 0 - 1			0 / 0 - 0.33
after 7 d	-	0/0	0/0	-	0/0	0/0

CF = control flank

TF = test flank

FD = found dead (not test item related, death due to accidental kidney damage)

M = male

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Based on the degree of skin reactions, classification of CA 2343 A (Intermediate of CGA 293343) according to OECD GHS and Council Directive 67/548/EEC is not required.

Executive summary:

An acute dermal irritation study in albino rabbits was performed to determine the irritant and corrosive potency of CA 2343 A (Intermediate of CGA 293343) on the albino rabbit skin. The study protocol was based on OECD Guideline No. 404. Some minor skin reations were being observed, with erythema and edema score reaching max. values of 1 at individual animals. All skin irritating effects were fully reversible within 7 days. Based on the degree of skin reactions, classification of CA 2343 A (Intermediate of CGA 293343) according to OECD GHS and Council Directive 67/548/EEC is not required.