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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
key study
Study period:
1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without no GLP - test substance was diluted before application (50 % end concentration).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(adopted may 1981).
Deviations:
yes
Remarks:
(test substance tested as 50% aqueous solution).
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3,4-Dichloroaniline-6-sulfonic acid
EC Number:
700-413-2
Cas Number:
6331-96-0
Molecular formula:
C6 H5 Cl2 N O3 S
IUPAC Name:
3,4-Dichloroaniline-6-sulfonic acid

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Source: Gaukler; D-6050 Offenbach/ Main, Frg.- Age at study initiation: no data.- Average weight at study initiation: 2.93 kg (male), 2.53 (female).- Housing: Individual caging in stainless steel cages with wire mesh walk floors; floor area = 40 cm x 51 cm.- Diet: Kliba 341, 4 mm; Klingenthalmuehle AG, CH-4303 Kaiseraugst, Switzerland; ad libitum (ca. 130 g/animal/day).- Water: ad libitum (ca. 250 mL tap water/animal/day).- Acclimation period: at least 8 days.ENVIRONMENTAL CONDITIONS- Temperature (°C): 20-24.- Humidity (%): 30-70.- Air changes (per hr): no data- Photoperiod (hrs dark / hrs light): 12/12.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: untreated skin of the same animal.
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied: ca. 0.5 g- Concentration (if solution): 50%
Duration of treatment / exposure:
4 hours
Observation period:
72 hours- readings were performed 30-60 min after removal of the test patches, as well as 24, 48 and 72 hours after the start of exposure.
Number of animals:
3 (2 males and 1 female)
Details on study design:
TEST SITE- Shaving of fur: at least 15 hours before treatment.- Area of exposure: 2.5 cm x 2.5 cm.- % coverage: at least 10% of entire body surface.- Type of wrap if used: four layers of absorbent gauze and pourous bandage.REMOVAL OF TEST SUBSTANCE- Washing (if done): yes (with lutrol and lutrol:water (1:1)).- Time after start of exposure: 4 hours.SCORING SYSTEM: OECD scoring system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(3 animals)
Time point:
other: 1, 24, 48 and 72 hours)
Score:
0
Max. score:
4
Reversibility:
other: not applicable.
Irritation parameter:
edema score
Basis:
mean
Remarks:
(3 animals)
Time point:
other: 1, 24, 48 and 72 hours).
Score:
0
Max. score:
4
Reversibility:
other: not applicable.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU