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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Remarks:
Study was performed prior to the update of the REACH Regulation and prior to the validation of in vitro test methods.
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Code of Federal Regulation, Section 1500.42
Deviations:
not specified
GLP compliance:
not specified
Remarks:
Study pre-dates GLP

Test material

Constituent 1
Reference substance name:
MCTR-7-75
IUPAC Name:
MCTR-7-75
Test material form:
other: no data
Details on test material:
- Name of test material: MCTR-7-75

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Zartman Farms, Douglassville, Pa.
- Weight at study initiation: 2.0 to 2.5 kg
- Housing: Housed and fed individually

Test system

Vehicle:
not specified
Controls:
other: The untreated right eye served as a control for each animal.
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
7 days
Observation period (in vivo):
No data
Number of animals or in vitro replicates:
7
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: Not done

SCORING SYSTEM: according to the Federal Register 38 (187) 27019 an animal should be considered as exhibiting a positive reasion if the test stubstace produced at any of the readings, ulceration of the cornea (other than a fine stippling); or opacity of the cornea (other than a slight duling of the normal lustre); or inflammation of the iris (other than a slight deepening of the folds, or rugae, or a slight circumcorneal injection of the blood vessels); or if such substances produce in the conjunctivae (excluding the cornea and iris) an obvious swelling with partial eversion or the lids or a diffuse crimson red with vessles not easily discernible.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
other: all animals tested (#1-6)
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
other: all animals tested (#1-6)
Time point:
24/48/72 h
Score:
2.6
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
other: all animals tested (#1-6)
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
other: animal #1, 3, 4 and 6
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3.6
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
3.33
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritant / corrosive response data:
All of the test animals exhibited severe irritation at 24, 48 and 72 h. At 4 days, four animals exhibited moderate irritation and two animals exhibited severe irritation. All animals exhibited moderate irritation at 7 days.
Other effects:
No data

Any other information on results incl. tables

Eye irritation in rabbits:

Animal No.

Cornea

A x B x 5

Iris

A x 5

Conjunctivae

(A + B + C) x 2

Total score

per animal

A

B

A

A

B

C

24 h

1

3

4

2

3

3

2

85

2

4

4

2

3

3

2

106

3

3

4

2

3

3

2

86

4

3

4

2

3

3

2

86

5

4

4

2

3

3

2

106

6

3

4

2

3

3

2

86

48 h

1

3

4

2

3

3

2

86

2

4

4

2

3

3

2

106

3

3

4

2

3

3

2

86

4

3

4

2

3

3

2

86

5

3

4

2

3

3

2

86

6

3

4

2

3

3

2

86

72 h

1

3

4

2

3

2

3

86

2

3

4

2

3

2

3

86

3

3

4

2

3

2

3

86

4

3

4

2

3

2

3

86

5

3

4

2

3

2

3

86

6

3

4

2

3

2

3

86

4 days

1

2

4

2

3

2

3

66

2

3

4

2

3

2

3

86

3

2

4

2

3

2

2

64

4

2

4

2

3

2

2

64

5

3

4

2

3

2

2

84

6

2

4

2

2

2

2

62

7 days

1

2

4

2

2

2

2

62

2

2

4

2

2

2

2

62

3

2

4

2

2

2

2

62

4

2

4

2

2

2

2

62

5

2

4

2

2

2

2

62

6

2

4

2

2

2

2

62

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The test material produced moderate to severe irritation for 7 days when instilled into the eye and not washed out.

The study meets generally accepted scientific standards; however substance identity is not adequately reported (although company records indicate the substance to be tripotassium orthophosphate) and as such this study is not considered to be acceptable for use as a stand-alone source of data but is considered acceptable for use as part of a weight of evidence approach in accordance with Annex XI, section 1.2 of Regulation (EC) No. 1907/2006 (REACH).