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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: According to guideline. Non-GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
BAS 560 F - (Benzoe-)Säure
IUPAC Name:
BAS 560 F - (Benzoe-)Säure
Details on test material:
- test substance number: 01/0246-1
- test substance: BAS 560 F - (Benzoe-)Säure
- batch: 30529/6

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Observation period (in vivo):
28 d
Number of animals or in vitro replicates:
2

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1 and #2
Time point:
other: 24 - 48 - 72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 28 days in animal #2
Remarks on result:
other: individual scores: 1 - 1 - 1
Irritation parameter:
iris score
Basis:
other: animal #1 and #2
Time point:
other: 24 - 48 - 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: individual scores: 1 - 1 - 1
Irritation parameter:
conjunctivae score
Basis:
other: animal #1 and #2
Time point:
other: 24 - 48 - 72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 28 days
Remarks on result:
other: individual scores: 3 - 3 - 3
Irritation parameter:
chemosis score
Basis:
other: animal #1 and #2
Time point:
other: 24 - 48 - 72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: individual scores: 3 - 2 - 2

Any other information on results incl. tables

Additional findings:

- 1h: severe discharge in both animals.

- 24h: severe discharge of blood in animal #1; slight discharge of blood in animal #2.

- 48h: suppuration, severe discharge of blood and loss of corneal tissue in animal #1; suppuration, slight discharge of blood in animal #2.

- 72h: suppuration, severe discharge of blood and loss of corneal tissue in animal #1; suppuration, slight discharge of blood, loss of corneal tissue and contracted pupil in animal #2.

- 7 day: loss of corneal tissue in animal #1; small retraction in eye lid, loss of corneal tissue and slight discharge.

- 14 days: small retraction in eye lid, loss of corneal tissue and vacuolization of the cornea circumscribed area into the central part in animal #2.

- 21 days: small retraction in the eyelid, loss of corneal tissue, vacuolization of the cornea circumscribed area into the central part in animal #2.

- 28 days: small retraction in the eyelid, loss of corneal tissue, study discontinued because of severe irritation, opacity, circle-like, about 0.5 cm diameter, opaque area with vascularization of the cornea, circumscribed, into the central part.

Applicant's summary and conclusion

Conclusions:
Based on the results of this study, the test substance needs to be classified Skin irrit. Cat 1 and R41, according to Regulation (EU) No. 1272/2008 and Directive 67/548/EEC, respectively.