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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
GLP-compliant study, available as unpublished report, adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Draize, J.H., Woodard, G., and Calvery, H.O., 1944
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Zinc bis(dibutyldithiocarbamate)
EC Number:
205-232-8
EC Name:
Zinc bis(dibutyldithiocarbamate)
Cas Number:
136-23-2
Molecular formula:
C18H36N2S4Zn
IUPAC Name:
zinc bis(dibutyldithiocarbamate)
Details on test material:
BUTASAN, off—white powder
Purity: 99.9 %

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: 1sf: (NZW), Isaac’s Farm, Litchfield, illinois
- Age at study initiation: young adult
- Weight at study initiation: 2.57 — 2.83 kilograms
- Housing: one per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: animals were quarantined for at least five days.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A mass of 39 mg, determined to occupy a volume of 0.1 ml of test material


Duration of treatment / exposure:
A single administration of the test material.
Observation period (in vivo):
Observations for signs of irritation were conducted on the first, second, and third days after dosing.
Number of animals or in vitro replicates:
3 males and 3 females per dose
Details on study design:
SCORING SYSTEM: The method of Draize (1944)

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
0.3
Max. score:
110
Reversibility:
fully reversible within: 48h
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
80
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
10
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
20
Reversibility:
fully reversible within: 48 hr
Irritation parameter:
chemosis score
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
The cornea and iris score were 0 at all time points in all animals. One rabbit had a conjunctivae score 4 and another a conjunctivae score 2 at 24 hr examination. In both cases irritation was resolved at 48 hr examination.

Applicant's summary and conclusion