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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
1 (reliable without restriction)

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)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N-[[(4-methylphenyl)sulfonyl]methyl]formamide
EC Number:
700-490-2
Cas Number:
36635-56-0
Molecular formula:
C9H11NO3S
IUPAC Name:
N-[[(4-methylphenyl)sulfonyl]methyl]formamide
Details on test material:
- Name of test material (as cited in study report): CGA 224433
- Physical state: Solid
- Analytical purity: approx 100%
- Lot/batch No.: P.709027
- Solubility in water: <1% at 20°C

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12-14 weeks
- Weight at study initiation: 2100 - 2600g
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12hr light cycle

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: contralateral flank of test animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g test material

VEHICLE
- Concentration (if solution): 0.5% carboxymethylcellulose and 0.1% polysorbate 80 in water
Duration of treatment / exposure:
72 hrs
Observation period:
1, 24, 48 & 72 hrs
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: at least 36cm2
- Type of wrap if used: aluminium foil over test gauze held with adhesive tape

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4hrs

SCORING SYSTEM:
Erythema and eschar formation:
0 = no erythema
1 = very slight erythema
2 = well defined erythema
3 = moderate to severe erythema
4 = severe erythema (beefy red) to slight eschar formation (injuries in depth)

Edema formation:
0 = no edema
1 = very slight edema
2 = well defined edema
3 = moderate to severe edema (raised approx 1mm)
4 = severe edema (raised more than 1mm and extending beyond area)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72hrs
Score:
>= 0
Max. score:
0
Reversibility:
other: No erythema
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72hrs
Score:
>= 0
Max. score:
0
Reversibility:
other: No edema

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No effects were seen for both erythema and edema testing on any animal. The test substance CGA 224433 can therefore be classified as non-irritant.
Executive summary:

Testing was performed to ascertain the irritant or corrosive potency of CGA 224433 tech.

No effects were observed for either erythema nor edema testing and therefore, based upon the results this substance can be classified according to the EC Directive No 83/467/1983 as non-irritant and requires no hazard symbol for this test.