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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
from 26 october 1994 to 2 november 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted in GLP compliance and in accordance with several internationally established guidelines (OECD, EEC guidelines, see below).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
SND 919 CL2 Y precursor 2
IUPAC Name:
SND 919 CL2 Y precursor 2
Test material form:
other: solid
Details on test material:
- Name of test material (as cited in study report): SND 919 CL2 Y precursor 2; 2,6-Diamino-4,5,6,7-tetrahydro-benzothiazol
- Physical state: solid
- Purity test date: 12 July 1994
- Lot/batch No.: KRÖ 27

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach an der Riß
- Age at study initiation: 19 - 22 weeks
- Weight at study initiation: 2.3 - 2.6 kg
- Housing: individually in stainless steel wire cages
- Diet (e.g. ad libitum): ad libitum; standard pelleted feed (Altromin, Lage
- Water (e.g. ad libitum): ad libitum; demineralized water, pH adjusted to 2.6 with hydrochloric acid
- Acclimation period: 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +3 -1 °C
- Humidity (%): 55 (50 - 65%)
- Photoperiod (hrs dark / hrs light): 12:12 hr light:darkness

Test system

Type of coverage:
other: occlusive and semi occlusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
yes, concurrent vehicle
Amount / concentration applied:
0.1 g test article moistened with 0.5 ml physiological saline
Duration of treatment / exposure:
4 hours
Observation period:
1 week
Number of animals:
2 males and 2 females
Details on study design:
TEST SITE
- Area of exposure: 3*3 cm dorsal area
- Type of wrap if used: gauze patch (Leukoflex Beiersdorf)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: cumulative irritation index
Remarks:
due to study age
Basis:
animal #1
Time point:
other: 1 hour to 1 week
Score:
0
Max. score:
0
Irritation parameter:
other: cumulative irritation index
Remarks:
due to study age
Basis:
animal #2
Time point:
other: 1 hour to 1 week
Score:
0
Max. score:
0
Irritation parameter:
other: cumulative irritation index
Remarks:
due to study age
Basis:
animal #3
Time point:
other: 1 hour to 1 week
Score:
0
Max. score:
0
Irritation parameter:
other: cumulative irritation index
Remarks:
due to study age
Basis:
animal #4
Time point:
other: 1 hour to 1 week
Score:
0
Max. score:
0
Irritant / corrosive response data:
No changes were observed on the skin of all 4 rabbits.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
On the basis of the respective regulations in the German Federal Republic (Gefahrstoff-Verordnung, 05.06.1991), SND 919 CL2 Y Precursor 2 (2,6-Diamino-4,5,6,7-tetrahydrobenzothiazole) does not require any special labelling, when assessed from the point of view of skin irritation.