Hydrazinium, 2-(3-methoxy-3-oxopropyl)-1,1,1-trimethyl-, bromide (1:1)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24.01. - 29.01.2005.

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

other: Body responsible for the test

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

463-070-5

EC Name:

-

Cas Number:

106966-25-0

Molecular formula:

C7H17N2O2Br

IUPAC Name:

2-(3-methoxy-3-oxopropyl)-1,1,1-trimethylhydrazinium bromide

Test animals / tissue source

Species:

other: Albino rabbit

Strain:

other: New Zealand Albino breed

Test system

Amount / concentration applied:

100 MG

Duration of treatment / exposure:

1 second

Observation period (in vivo):

The eyes were examined at 1, 24, 48 and 72 hours after application.

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

0.67

Results 2

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

0.33

Max. score:

2

Remarks on result:

other: Max. duration: 24 h; Max. value at end of observation period: 0 (related to all animals)

Results 3

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

0.33

Results 4

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

0

Max. score:

1

Remarks on result:

other: Max. duration: 24 h; Max. value at end of observation period: 0 (related to all animals)

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

0

Results 6

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: Max. duration: 24 h; Max. value at end of observation period: 0 (related to all animals)

Results 7

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

0

Results 8

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: Max. duration: 24 h; Max. value at end of observation period: 0 (related to all animals)

Irritant / corrosive response data:

Reversibility of any observed effect: Changes fully reversible within 2 days

Other effects:

No other observations.

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

There were three rabbits in initial test and three rabbits in the main test. The following changes in main test were observed on eye of animals 24 hours after application: in rabbit No.6 – some blood vessels were hyperaemic (injected); in rabbit No.4 diffuse crimson color, individual vessels not easily discernible, vehement lacrimation and some swelling above. All changes faded till 48 hours after application. Rabbit No. 5 died until 2-3 minutes after application of the test substance. Iris of both eyes did not react to light after application (cause of death was not found out). In two others the rapid breathing, lacrimation and serous discharge out of nose were observed.
3-(2,2,2-Trimethylhydrazine)methylpropionate bromide does not have to be classified as irritation for eye.