Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 November to 09 December 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study undertaken in a GLP accredited laboratory to internationally recognised gudelines.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye 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 / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Commercial laboratory animal supplier.
- Age at study initiation: Twelve to twenty weeks
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: The animals were 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): Twelve hours continuous light, 0600h to 1800h and 12 hours dark.

IN-LIFE DATES: From: To:

Test system

Vehicle:
water
Controls:
other: The left eye remained untreated and was used for control purposes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 29 mg
- Concentration (if solution): 10% w/w aqueous preparation

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of treatment / exposure:
Irnmediately after administration of the test material, an assessment of the initial pain reaction was made.
Observation period (in vivo):
1, 24 48 and 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data.
- Time after start of exposure: 1, 24, 48 and 72 hours.

SCORING SYSTEM:Draize scale for scoring ocular irritation and a modified Kay and Calandra interpretation of the eye irritation test.

TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1 hour
Score:
6
Max. score:
1
Reversibility:
fully reversible within: 48 hours of dosing
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 hours
Score:
2
Max. score:
1
Reversibility:
fully reversible within: 48 hours of dosing
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 48 hours
Score:
0
Max. score:
0
Reversibility:
not fully reversible within: 48 hours of dosing
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 72 hours
Score:
0
Max. score:
0
Reversibility:
not fully reversible within: 48 hours of dosing
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1 hour
Score:
6
Max. score:
1
Reversibility:
fully reversible within: 48 hours of dosing
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24 hours
Score:
4
Max. score:
1
Reversibility:
fully reversible within: 48 hours of dosing
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 48 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 48 hours of dosing
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 48 hours of dosing
Irritant / corrosive response data:
Initial Pain Reaction (IPR), will be graded as follows:

Class Reaction by Animal Descriptive Rating
0 No response No initial pain
1 A few blinks only, normal within one or twominutes Practically no initial pain
2 Rabbit blinks and tries to open eye, but reflex closes it Slight initial pain
3 Rabbit holds eye shut and puts pressure on lids, may rub eye with paw Moderate initial pain
4 Rabbit holds eye shut vigorously, may squeal Severe initial pain
5 Rabbit holds eye shut vigorously, may squeal, claw at eye, jump and try to escape Very severe initial pain

There is often no correlation between the initial pain and the subsequent eye irritation.

All three rabbits had an IPR of 2.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material produced a maximum group mean score of 4.0 and was classified as a minimal irritant (Class 3 on a I to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. Consequently this substance is not classified for eye irritation.