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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
17 to 20 March 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without GLP; the tested substance is a precursor or Reactive Black 5 Bis-Vinyl and hydrolyses in aqueous solution from the bis-ester to the bis-vinyl form

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Federal Register 38, No 187
Principles of method if other than guideline:
Federal Register 38, No 187
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Reactive Black 5
IUPAC Name:
Reactive Black 5
Details on test material:
Remazol Schwarz GF VP 5152

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG
- Weight at study initiation: 1.6 to 2.1 kg
- Housing: single
- Diet (e.g. ad libitum): Standard food ERKA 8300
- Water (e.g. ad libitum): tap water
- Acclimation period: NA


IN-LIFE DATES: From: 17. March To: 20. March 1980

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg pasted with 1 drop physiological saline solution
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
The test item was applied to the left eye of each rabbit. The contra-lateral eye surved as intra-individual control. Evaluation 1, 7, 24, 48, and 72 hours after test item application by means of a magnifying lens. After 24 hours the eyes were rinsed with physiological saline solution. At 48 and 72 hours evaluation, fluorescein staining was used to verify the absence of corneal lesions.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 7 hours
Score:
11
Max. score:
110
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1 hour
Score:
10
Max. score:
110
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 24 hours
Score:
5
Max. score:
110
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 48 hours
Score:
2
Max. score:
110
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 72 hours
Score:
1
Max. score:
110
Other effects:
no effects

Any other information on results incl. tables

 

Classification Index

0-10       non irritating

11-25     slightly irritating

26-56     moderately irritating

57-110   severely irritating

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Classification according to EC: not irritating
slightly irritating according to Federal Register 38, No 187