Guanidine, N-methyl-N'-nitro-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996-07-05 till 1996-08-07

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:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

433-400-2

EC Name:

-

Cas Number:

4245-76-5

Molecular formula:

C2H6N4O2

IUPAC Name:

1-Methyl-3-nitro-guanidine

Constituent 2

Reference substance name:

N-methyl-N'-nitro-guanidine

IUPAC Name:

N-methyl-N'-nitro-guanidine

Details on test material:

- Name of test material (as cited in study report): CA 2342 A (Intermediate of CGA 293343)
- Substance type: intermediate
- Physical state: solid
- Analytical purity: 98%
- Purity test date: reanalysis date December 1997
- Lot/batch No.: P.601014
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: room temperature

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 month
- Weight at study initiation: 3120 to 3530 g
- Housing: The animals were housed individually in metal cages
- Diet (e.g. ad libitum): ad libitum standard rabbit pellet - NAFAG 814
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3° C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: A control gauze patch was applied to the contralateral flank of each animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g per animal

VEHICLE
- Amount(s) applied (volume or weight with unit): Before application both patches were moistened with distilled water.

Duration of treatment / exposure:

4 hours

Observation period:

72 hours after removal of patch

Number of animals:

three males

Details on study design:

TEST SITE
- Area of exposure: approx. 6 cm2
- % coverage:
- Type of wrap if used: The patches were loosely covered with an aluminum foil (approx. 36 cm2) and held in place by an adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

SCORING SYSTEM: The degree of skin reactions was evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD
scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1, 24, 48, and 72 hours

Score:

0

Max. score:

0

Reversibility:

other: not applicable (erythema score 0)

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1, 24, 48, and 72 hours

Score:

0

Max. score:

0

Reversibility:

other: not applicable (edema score 0)

Irritant / corrosive response data:

All three animals showed an erythema score and edema score of zero, throughout the whole test duration

Other effects:

A slight loss of body weight was observed on experimental day 3 in one animal.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Since the mean irritation scores 24 to 72 hours after application were below the thresholds defined in Commission Directive 93/21/EEC (18th adaptation to technical progress of Council Directive 67/548/EEC), classification of CA 2342 A (Intermediate of CGA 293343) as to its skin irritating properties is not required. This classification still applies to the recent versions of both UN-GHS and EU-GHS (CLP).

Executive summary:

An acute dermal irritation/corrosion study was performed to determine the irritant and corrosive potency of CA 2342 A (Intermediate of CGA 293343) on the albino rabbit skin. The study protocol was based on OECD Guideline No. 404, adopted July 17, 1992, and on Annex V, part B of Council Directive 79/831/EEC, 1992.

There were no skin reactions in all rabbits 1 through 72 hours after gauze patch removal. The test was concluded after the 72 hour evaluation. All animals survived to the scheduled sacrifice. There were no remarkable in-life observations. A slight loss of body weight was observed on experimental day 3 in one animal.

Since the mean irritation scores 24 to 72 hours after application were below the thresholds defined in Comission Directive 93/21/EEC (18th adaptation to technical progress of Council Directive 67/548/EEC), classification of CA 2342 A (Intermediate of CGA 293343) as to its skin irritating properties is not required. This classification still applies to the recent versions of both UN-GHS and EU-GHS (CLP).