Chrome antimony titanium buff rutile

Eye irritation

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: Observation period shorter than described in OECD Guideline 405

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Reference 2

Reference Type:

secondary source

Title:

C.I. Pigment Brown 24

Author:

OECD

Year:

2002

Bibliographic source:

SIDS Initial Assessment Report for SIAM 15

Materials and methods

Principles of method if other than guideline:

Before OECD Guideline 405 was established, eye irritation was tested according to Federal Register 38, No. 187, § 1500.42, S. 27019, 27. Sept. 1973

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Chrome antimony titanium buff rutile

EC Number:

269-052-1

EC Name:

Chrome antimony titanium buff rutile

Cas Number:

68186-90-3

Molecular formula:

(Ti, Sb, Cr) O2

IUPAC Name:

manganese(4+) trititanium(4+) pentaantimony(3+) chromium(3+) nickel(2+) octadecaoxidandiide

Test material form:

solid

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Mean weight at study initiation: 2.4 kg
- Diet: Sniff

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 100 mg

Duration of treatment / exposure:

unspecified

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: not performed


SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.83

Max. score:

3

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: reversibility unclear in 3/6 animals

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: reversibility unclear

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: reversibility unclear

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: reversibility unclear

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 10

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Other effects:

Secretion was observed in four and one animal after 24 and 48 hours, respectively.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met