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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 06 JUN 2011 to 21 JUN 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study, in compliance with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Biological Evaluation of Medical Devices, Part10: Tests for irritation and Sensitization
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N-(5-chloro-2,4-dimethoxyphenyl)-4-[[5-[(diethylamino)sulphonyl]-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide
EC Number:
229-107-2
EC Name:
N-(5-chloro-2,4-dimethoxyphenyl)-4-[[5-[(diethylamino)sulphonyl]-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide
Cas Number:
6410-41-9
Molecular formula:
C30H31ClN4O7S
IUPAC Name:
N-(5-chloro-2,4-dimethoxyphenyl)-4-{[5-(diethylsulfamoyl)-2-methoxyphenyl]diazenyl}-3-hydroxy-2-naphthamide
Test material form:
solid: nanoform, no surface treatment
Details on test material:
Name of test material (as cited in study report): DCC Carmine FBSX
Analytical purity: C.I. Pigment Red 5: > 92%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: DNA Rabbitry, Elk River, MN, USA
- Age at study initiation: young adults
- Weight at study initiation: 2.6 kg (male), 2.3 kg (female), 2.2 kg (male)
- Housing: individual boxes
- Diet: standard laboratory diet, ad libitum
- Water: tap water from public distribution system, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- According to AAALAC International recommendations for rabbits

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: control: wetted patch; positive control: 2.5% and 5% sodium lauryl sulfate
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): a not further quantified amount of tap water was used to moisten the test item
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
3 (2 males, 1 female)
Details on study design:
TEST SITE
- Area of exposure: approximately 2.5 x 2.5 cm
- Type of wrap if used: gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): diluted alcohol
- Time after start of exposure: 24 h

SCORING SYSTEM: in accordance with OECD TG 404, reading at 1, 24, 48 and 72 h after removal of test item

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
- No erythema or oedema were observed at any time point.
Other effects:
- no clinical signs recorded
- A red coloration was noted on the treated areas which made it difficult to score for erythema

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item is not irritating to skin under the test conditions described above. Skin exposure was longer (24 h) than recommended in OECD TG 404 (4 h). No dermal reactions, neither erythema nor edema, were observed.
Executive summary:

The primary skin irritation potential of the test item was investigated according to Biological Evaluation of Medical Devices, Part10: Tests for irritation and Sensitization.

0.5 g of the test item moistened with tap water was applied to the intact skin of three New Zealand White rabbits under semi-occlusive conditions for twenty four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the test item. A red discoloration was noted on the treated are. No skin reactions, neither erythema nor edema, were observed at any time point (score 0). No signs of systemic toxicity were observed.

Therefore, it is concluded that the test item is not irritating to skin.