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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The exposure duration was 24 hours. No 48-hour observation point included.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1955).
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
24h occlusive application and short post-observation period. No recording of body weight development and clinical signs.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Calcium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate
EC Number:
230-303-5
EC Name:
Calcium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate
Cas Number:
7023-61-2
Molecular formula:
C18H13ClN2O6S.Ca
IUPAC Name:
calcium 4-[(5-chloro-4-methyl-2-sulfonatophenyl)diazenyl]-3-hydroxy-2-naphthoate
Test material form:
solid: nanoform
Details on test material:
Batch: EG 9146
Appearance: red powder

Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.
Specific details on test material used for the study:
- Appearance: red powder
- Batch No.: EG 9146

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Healthy New Zealand White rabbits (Porton strain) aged 10 - 13 weeks with average body weights of 2.84 Kgs {males) and 2.58 Kgs (females), bred on the premises and maintained under a semi-barrier system. Six rabbits (3 males and 3 females) were acclimatized in the test area for one week prior to the start of the trial.

The rabbits were caged singly in an experimental room maintained at a temperature of 20°C. (± 1°) and a relative humidity of 50-70%. Animals were exposed to artificial light for 10 hours daily from 08.00 - 18.00 hours. A commercial irradiated diet (Styles-Oxoid) was fed ad lib. Sterile filtered water was available at all times.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: both shaved and abraded
Vehicle:
other: 50% polyethylene glycol in water
Controls:
not required
Amount / concentration applied:
10 g of the test compound was mixed with 20 mL of deionized water to form a suspension, of which 1.5 mL was applied to the test sites on 2.5 cm square gauze pads (dose of 0.5 g per application site).
Duration of treatment / exposure:
24h
Observation period:
After 24 hours the dressing was removed and the intact and abraded application sites were assessed for oedema and erythema. A further assessment was made at 72 hours.
Number of animals:
3 males and 3 females
Details on study design:
Twenty-four hours prior to dermal application, the backs of the rabbits were shaved over an area consisting of at least 10% of the total body surface. Two sites lateral to the midline of the back were used on each rabbit. Immediately before the application of the compound, the right hand side was abraded with the point of a sterile hypodermic needle. The abrasions were sufficiently deep to penetrate the stratum corneum but not to damage the dermis. The left hand side remained intact.

10g of the compound mixed with 10ml of a 50% aqueous solution of polyethylene glycol to make a suspension of 20ml, 1.0ml of which was applied to each test site on a 2.5cm square gauze pad. These were covered with aluminium foil secured with "Sleek" adhesive tape

After 24 hours the dressing was removed and the intact and abraded application sites were assessed for oedema and erythema. A further assessment was made at 72 hours and f or any further period considered necessary up to 14 days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h and 72h
Score:
0
Max. score:
4
Remarks on result:
other: values for intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
other: values for intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
other: values for abraded skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
other: values for abraded skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not determinable
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not determinable

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met