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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
18 to 26 November 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study undertaken in a GLP accredited laboratory to internationally recognised guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
T-1215A
IUPAC Name:
T-1215A
Constituent 2
Chemical structure
Reference substance name:
3-(3,5-di-tert-butyl-4-hydroxyphenyl)-N-octadecylpropanamide
EC Number:
700-596-9
Cas Number:
14442-94-5
Molecular formula:
C35H63NO2
IUPAC Name:
3-(3,5-di-tert-butyl-4-hydroxyphenyl)-N-octadecylpropanamide
Constituent 3
Reference substance name:
3-{3,5-Di-tert-butyl-4-hydroxyphenyl}-N-octadecyl-propionamide
IUPAC Name:
3-{3,5-Di-tert-butyl-4-hydroxyphenyl}-N-octadecyl-propionamide
Details on test material:
- Name of test material (as cited in study report): T-1215A (3-(3,5-Di-tert-butyl-4-hydroxyphenyl)-N-octadecyl-propionamide)
- Substance type: Solid
- Physical state: Powder
- Analytical purity: 97.1% (measured by GC)

- Impurities (identity and concentrations):
3-(3,5-Di-tert-butyl-4-hydroxyphenyl)-N-hexadecyl-propionamide; 1.3%
3-(3,5-Di-tert-butyl-4-hydroxyphenyl)-N-heptadecyl-propionamide; 1.6%

- Purity test date: 28 October 2004
- Lot/batch No.: 04HY1101
- Stability under test conditions:
- Storage condition of test material: Room temperature in the dark
- Other:

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Commercial laboratory animal supplier.
- Age at study initiation: twelve to twenty weeks old.
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: Individually housed in suspended metal cages.
- Diet: Certified Rabbit Diet (Code 5322), ad libitum
- Water: ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23
- Humidity (%): 30 to 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours light, 0600h to 1800h, and 12 dark.

IN-LIFE DATES: From: To:

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
- Concentration (if solution): water

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of treatment / exposure:
3 minutes, 1 hour and 4 hours.
Observation period:
1, 24, 48 and 72 hours.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage:
- Type of wrap if used: Each patch was secured in position with a strip of surgical adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 3minutes, 1 hour and 4hours after application

SCORING SYSTEM:
Draize classification scheme.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Remarks on result:
other: 3 minute exposure
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Remarks on result:
other: 1 hour exposure
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Remarks on result:
other: 4 hour exposure
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Remarks on result:
other: 3 minute exposure
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Remarks on result:
other: 1 hour exposure
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Remarks on result:
other: 4 hour exposure

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.