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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Range-finding study, test procedure in accordance with national standard methods with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Guideline:
other: according to Federal Hazardous Substances Act (FHSA) procedure
Principles of method if other than guideline:
In the FHSA test six eyes are exposed, but not rinsed. A fixed dose of 0.1 ml of Dimethylaminopropyl methacrylamide is used. This is placed inside the lower eyelid, which forms a culdesac. Ocular reactions are read either with the unaided eye or a magnifier at 24, 48 and 72 h after exposure. In
the FHSA test, no readings after 72 h are specified. Use of fluorescein after 24-h reading is optional in the FHSA version, but is not mentioned in
the Draize procedure. Readings are recorded as separate scores for lesions of the cornea, iris, and conjunctiva. Serious lesions such as pannus,
phlyctena, or ulceration of the cornea are considered to be off-scale responses that are to be noted separately.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): Dimethylaminopropyl Methacrylamide
- Molecular weight (if other than submission substance): 170.25 g/mol

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: no data
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eyes of the test animals serve as the control
Amount / concentration applied:
undiluted
Amount applied: 0.1 ml
Duration of treatment / exposure:
72 hour(s)
Observation period (in vivo):
no data
Number of animals or in vitro replicates:
4
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no removal of the test substance


SCORING SYSTEM: Draize J.H. et al. (1944) (original values)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Primary irritation index
Basis:
mean
Remarks:
according to Scoring system of Draize et al. 1944
Time point:
24/48/72 h
Score:
66.3
Max. score:
110
Reversibility:
not specified
Remarks on result:
other: A corrosive-like action to the eye lids of 4 rabbits was determined. The iris could not be viewed because of corneal opacity in 3 of 4 rabbits.
Remarks:
Reversibility scores were not measured after 7 and 21 days.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
60
Reversibility:
not specified
Remarks on result:
other: mean of the three time points
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
80
Reversibility:
not specified
Remarks on result:
other: mean of the three time points
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
80
Reversibility:
not specified
Remarks on result:
other: mean of the three time points
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
80
Reversibility:
not specified
Remarks on result:
other: mean of the three time points
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
5
Reversibility:
not specified
Remarks on result:
other: mean of the three time points
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
other: mean of the three time points
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
other: mean of the three time points
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
other: mean of the three time points
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
16
Reversibility:
not specified
Remarks on result:
other: mean of the three time points
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
16
Reversibility:
not specified
Remarks on result:
other: mean of the three time points
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
16
Reversibility:
not specified
Remarks on result:
other: mean of the three time points
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
16
Reversibility:
not specified
Remarks on result:
other: mean of the three time points
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
not measured/tested

Any other information on results incl. tables

Classification of eye irritation studies according GHS-criteria/original values

 

Substance: 3-Dimethylaminopropyl methacrylamide                         DMAPMA                           CAS: 5205-93-6

 

Internal No.: LITSU 96-0160

 

Date/Expert: 06-12-18/Am

 

Evaluation at the end of the table

 

Animal No.

Corneal opacity/Hornhauttrübung[Scores]

 orignal values

Mean Draize score

Reversibility

[scores]

Hazard category

after 24 h

after 48 h

after 72 h

in 7 days

in 21 days

 

1

60 

60 

60 

 

 

 

 

2

80 

80 

80 

 

 

3

80

80 

80 

 

 

 

 

4

80 

80 

80 

 

 

 

 

 

 

 

 

 

 

 

Animal No.

Iritis/Regenbogenhautentzündung[Scores]

original values 

Mean Draize score

Reversibility

[scores]

Hazard category

after 24 h

after 48 h

after 72 h

in 7 days

in 21 days

 

1

 5

5

 

 

 

2

0

 0

0

 

 

3

 0

 

 

 

0

 0

 

 

 

 

 

 

 

 

 

 

 

Animal No.

Conjunctiva /Bindehautrötung/ödem[Scores]

original values

Mean Draize score

Reversibility

[scores]

Hazard category

after 24 h

after 48 h

after 72 h

in 7 days

in 21 days

 

1

16

16 

 16

 

 

2

16 

16 

 16

 

 

 

3

16

16

 16

 

 

 

4

16 

16

16 

 

 

 

There was a discernible opacity or ulceration of the cornea during the readings made at 24, 48 or 72 hours. There was an obvious swelling of the conjunctivae, excluding cornea and iris, with partial eversion of the lids.There was destruction or irreversible change at any tissue in 24 hours or less.

The iris could not be viewed because of corneal opacity in 3 of 4 rabbits.

A corrosive-like action to the eye lids of 4 rabbits. Corneal opacity in 3 of 4 rabbits!

 

Classification GHS:

Hazard Category

1

irreversible effects




Classification Criteria for serious Eye Damage/Eye Irritation

 

Category 1

 

  • Irreversible damage to cornea, iris, conjunctiva 21 days after exposure in at least one animal
  • Mean Draize score in 2 of 3 animals:

     corneal opacity≥ 3

     iritis ≥ 1,5

 

 

Category 2

 

  • Reversible adverse effects on cornea, iris, conjunctiva
  • Mean Draize score in 2 of 3 animals:

corneal opacity1

iritis1

redness2

chemosis2

 

 

Subcategory 2A

 

  • Reversible in 21 days

 

Subcategory 2B

 

  • Reversible in 7 days

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Dimethylaminopropyl methacrylamide has a corrosive-like action to the eye lids of 4 rabbits. Effects on the iris could not be evaluates in 3 of 4 rabbits due to severe corneal opacity.

Classification: risk of serious damage to eyes, GHS-category: 1, H318, causes serious eye damage
Executive summary:

In a primary eye irritation study, 0.1 mL of Dimethylaminopropyl methacrylamide (purity: >= 98%) was instilled into the conjunctival sac of 4 rabbits (strain, sex, source, age, weight: no data) for 72 hours. The eyes were not washed. Irritation was scored by the method of Draize et al. (1944).

In this study, Dimethylaminopropyl methacrylamide was a strong eye irritant. It was found to have a corrosive-like action to the eye lids of the rabbits and induced changes of the eye which were considered irreversible.

Based in EU and OECD criteria the DMAPMA is considered a category 1 eye irritant with the potential to cause irreversible damage to the eye.

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