Morpholinium sulphamate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2012-10-09 until 2012-10-16

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

24 April 2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

30 May 2008

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Version / remarks:

August 1998

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Morpholinium sulphamate

EC Number:

258-061-6

EC Name:

Morpholinium sulphamate

Cas Number:

52636-67-6

Molecular formula:

C4H9NO.H3NO3S

IUPAC Name:

morpholin-4-ium sulfamate

Test material form:

solid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: S & K LAP Kft. 2173 Kartal, Császár út 135, Hungary
- Age at study initiation: young adult male rabbits
- Weight at study initiation: 2834-3195 g
- Weight at end of study: 3077-3195
- Housing: Animals were housed individually in metal cages.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 18 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3°C
- Humidity: 30 - 70 %
- Air changes (per hr): 9-12
- Photoperiod (hrs dark / hrs light): 12 hours artificial light, from 6 a.m. to 6 p.m.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

A weight of 0.1 g of the undiluted and well grinded test item morpholinium sulphamate was used for the study in a single dose.

Duration of treatment / exposure:

The eyes of the test animals were not washed out after the application of test item.

Observation period (in vivo):

The eyes were examined at 1, 24, 48 and 72 hour(s) and then at 1 and 2 weeks after the application.

Number of animals or in vitro replicates:

3 male animals

Details on study design:

SCORING SYSTEM: The eye irritation scores were evaluated according to the scoring system by Draize (1979) and OECD 405 (24 April 2002)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 7

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 1 week

Results 8

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 1 week

Results 9

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 1 week

Results 10

Irritation parameter:

conjunctivae score

Remarks:

discharge

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 1 week

Results 11

Irritation parameter:

conjunctivae score

Remarks:

discharge

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 1 week

Results 12

Irritation parameter:

conjunctivae score

Remarks:

discharge

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 1 week

Results 13

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 1 week

Results 14

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 1 week

Results 15

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 1 week

Irritant / corrosive response data:

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

One hour after treatment, some hyperemic blood vessels (score 1) were observed in two animals and diffuse, crimson coloured conjunctivae with not easily discernible individual vessels (score 2) occurred in one animal. The obvious swelling with partial eversion of lids (score 2) was detected in one animal and the conjunctival swelling with lids about half closed (score 3) was detected in two animals. The discharge with moistening of the lids and hairs just adjacent to lids (score 2) were observed in two animals and the discharge moistened lids and hairs on considerable area around the treated eye (score 3) was recorded in one animal.

24 hours after treatment, some hyperemic blood vessels (score 1) were observed in two animals and diffuse, crimson coloured conjunctivae with not easily discernible individual vessels (score 2) occurred in one animal. The obvious swelling with partial eversion of lids (score 2) was detected in all animals. The discharge with moistening of the lids and hairs just adjacent to lids (score 2) were observed in two animals and the amount of the discharge was different from normal (score 1) in one animal.

48 hours after treatment, some hyperemic blood vessels (score 1) were observed in all animals. The swelling was different from normal (score 1) in all animals and the amount of the discharge was different from normal (score 1) in two animals.

72 hours after the treatment, some hyperemic blood vessels (score 1) were observed in all animals and the swelling was different from normal (score 1) in one animal.

1 week after the treatment the study was terminated, since no primary irritation symptoms occurred.

During the study the control eyes of the animals were symptom-free.

General state and the behaviour of the animals were normal throughout the study period. There were no effects on body weight attributable to the treatment with the test item during the contact and observation period.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In conclusion, test item morpholinium sulphamate applied to the rabbits' eye mucosa, caused slight to severe irritation effects on the conjunctiva within one hour after test item administration. The condition of the conjunctiva improved within 24 hours (slight to moderate effects) and 72 hours (slight effects) and the observed effects were fully reversible within 1 week.

Executive summary:

The acute eye irritation study of the test item morpholinium sulphamate was performed in three New Zealand White rabbits. The irritation effect of the test item was evaluated according to the method by Draize (1979) and OECD No.: 405, 2002. The test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. A weight of 0.1 g of the test item was used in well grinded state, as a single dose. The eyes of the test animals were not washed out after the application of test item. The eyes were examined at 1, 24, 48 and 72 hours then 1 week after the application. One hour after the treatment, slight to moderate conjunctival redness, moderate to severe chemosis and moderate to severe discharge were observed. 48 hours after the treatment, slight redness, chemosis and discharge were recorded. 1 week after the treatment, all animals became free of symptoms. 1 week after treatment the study was terminated, as all animals were free of symptoms of irritation.

The animals’ mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows:

cornea opacity: 0.00, 0.00, 0.00

iris: 0.00, 0.00, 0.00

redness: 1.00, 1.33, 1.00

chemosis: 1.00, 1.00, 1.33

discharge: 1.00, 1.00, 0.33

In conclusion, test item morpholinium sulphamate applied to the rabbits' eye mucosa, caused slight to severe irritation effects on the conjunctiva within one hour after test item administration. The condition of the conjunctiva improved within 24 hours (slight to moderate effects) and 72 hours (slight effects) and the observed effects were fully reversible within 1 week. According to CLP criteria for classification and labelling requirements for dangerous substances and preparations, the test item does not have to be classified and has no obligatory labelling requirement for eye irritation. According to Regulation (EC) No 1272/2008, the test item has not been classified into any category.