Guanidine, N-methyl-N'-nitro-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996-07-11 till 1996-08-09

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline-conform study 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 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

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 on 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GMBH, D-88397 Biberach, Germany
- Age at study initiation: no data
- Weight at study initiation: 3560 to 3992 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): tap water ad libitum
- Acclimation period: at least five 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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: control area on the same animal (right eye)

Amount / concentration applied:

100 ml, i.e. 47 mg per animal

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

three females

Details on study design:

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


SCORING SYSTEM: OECD scoring system


TOOL USED TO ASSESS SCORE: no data

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, and 72 hours after treatment

Score:

0

Max. score:

0

Reversibility:

not specified

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, and 72 hours after treatment

Score:

0 - 0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, and 72 hours after treatment

Score:

0 - 0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, and 72 hours after treatment

Score:

0 - 0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

Mean scores of 24 through 72 hours after ocular administration indicated moderate circumcorneal hyperemia of the iris in rabbit no. 424.
Conjunctival hyperemia with injected blood vessels was noted in all rabbits, and above normal swelling of eye lids in one rabbit.
The observed eye reactions were completely reversible in all rabbits within 2 days.

Other effects:

Body weights (Table 2) were unaffected by the treatment. There were no remarkable in-life observations.

Any other information on results incl. tables

animal no.	424	480	482
conjunctiva / redness	0.33	0.33	0.33
conjunctiva / chemosis	0.33	0	0
cornea	0	0	0
iris	0.33	0	0

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 instillation 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 eye 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 eye irritation/corrosion study was performed with White New Zealand Rabbit acc. to OECD Guideline 405.

Mean scores of 24 through 72 hours after ocular administration indicated moderate circumcorneal hyperemia of the iris in one rabbit. Conjunctival hyperemia with injected blood vessels was noted in all rabbits and above normal swelling of eye lids in one rabbit. The observed eye reactions were completely reversible in all rabbits within 2 days. All animals survived to the scheduled sacrifice. There were no remarkable in-life observations.

Since the mean irritation scores 24 to 72 hours after instillation 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 eye irritating properties is not required. This classification still applies to the recent versions of both UN-GHS and EU-GHS (CLP).