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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
The test was conducted by means of Read Across approach. Further information was attached at section 13

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Principles of method if other than guideline:
BASF internal testing method
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Vat Orange 002 - Similar Substance 01
IUPAC Name:
Vat Orange 002 - Similar Substance 01
Test material form:
solid

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Talcum
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 mg
Duration of treatment / exposure:
1 hour
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
no data
Details on study design:
Animals were observed after 1, 24 hours and 8 days.

SCORING SYSTEM:
Erythema and Edema
Ø - no effect
(+) - questionable
+ - mild
++ - moderate
+++ - marked

R - erythema
Ö - edema
Sch - desquamation
N - necrosis
Tr - opacity
Na - scar

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 8 d
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 8 d
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 8 d
Max. score:
3
Reversibility:
other: inconclusive
Remarks on result:
other: inconclusive
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 8 d
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Within the first hour, slight redness occurred and lasted until day 8. Since the observation period stopped at day 8, no conclusion can be done on the reversibility. No signs of corrosion observed.

The positive control (Talcum) caused slight irritation after 24 h which was fully reversible within 8 days.

Any other information on results incl. tables

Table 1: Results on Eye Irritation

Findings after
1 hour 24 hours 8 days
Test item R+/Ö+/black substance residues  R+ R+
Talcum  R+/Ö+  R+ Ø

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
The substance caused slight redness in rabbit eyes. However, the observation period stopped at day 8, no conclusion can be done on reversibility and severity of the redness. Therefore, the study is not used for classification purposes.
Executive summary:

The substance caused slight redness in rabbit eyes. However, the observation period stopped at day 8, no conclusion can be done on reversibility and severity of the redness. Therefore, the study is not used for classification purposes.