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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the OECD TG 404 and followed GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(1987)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
A mixture of: N,N-diethylpropane-1,3-diamine 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate; 2,2-iminodiethanol 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate; 2-methylaminoethanol 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate
EC Number:
403-410-1
EC Name:
A mixture of: N,N-diethylpropane-1,3-diamine 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate; 2,2-iminodiethanol 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate; 2-methylaminoethanol 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate
Cas Number:
114565-65-0
Molecular formula:
C18 H16 N8 O3 S2 . x C7 H18 N2 . x C4 H11 N O2 . x C3 H9 N O
IUPAC Name:
(3-aminopropyl)diethylamine; 2-(methylamino)ethan-1-ol; 2-[(2-hydroxyethyl)amino]ethan-1-ol; 6-methyl-2-{4-[2-(triaminopyrimidin-5-yl)diazen-1-yl]phenyl}-1,3-benzothiazole-7-sulfonic acid
Details on test material:
- Name of test material (as cited in study report): FAT 11'184/B
- Physical state: powder
- Analytical purity: No data mentioned in the report. However, in an Ames test report (CCR 124312, see IUCLID chapter 7.6.1) using the same batch of test substance the analytical purity was given as 89.6%.
- Lot/batch No.: Op. 1 BD 823/8
- Expiration date of the lot/batch: January, 1993
- Stability under test conditions: test substance in dilution is stable for at least 2 hours

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Designation: New Zealand White, KFM (SPF-Quality)
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf / Switzerland
- Age at study initiation: 14 - 15 weeks
- Weight at study initiation: 2.6 - 3.2 kg
- Housing: individually in stainless steel cages with automatic cleaning and drinking system
- Diet: Pelleted standard Kliba 341, Batch 32/87 rabbit maintenance diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 40 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: the untreated skin of each animal served for control
Amount / concentration applied:
Approximately 24 hours before treatment, the dorsal fur of each test animal was shaved. About 0.5 g of the with tap water moistened test article was applied to the intact skin of the shaved area; the application site was covered with a patch (3 cm x 3 cm) which again was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage.
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
Three animals were used (1 male, 2 females)
Details on study design:
EVALUATION OF SKIN REACTION
Four hours after the application, the dressing was removed and the skin was flushed with lukewarm tap water. The skin reaction was assessed according to the Draize scoring system, as recommended by the OECD TG 404. The skin reaction was assessed at 1, 24, 48 and 72 hours intervals after the removal of the dressing, gauze patch and test article.

FURTHER OBSERVATIONS
The animals were daily checked for mortality and clinical symptoms; body weights were recorded on the day of application and at test termination. At the end of the 72 hour-observation period the animals were sacrificed by intravenous injection of T61 and were discarded.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: none of the 3 animals showed erythema
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: none of the 3 animals showed edema
Irritant / corrosive response data:
Neither erythema nor edema was observed, thus, the test article was not irritating to the skin of rabbit.
Other effects:
Each of the 3 test animals displayed a yellow to orange staining of the treated skin by pigment or colouring of the test article; staining was seen in all animals at all reading time points.
Moreover, neither mortality nor toxic symptoms were observed, and body weight gain of all rabbits was similar.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified