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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 4, 1984 - December 7, 1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed according to OECD guideline 404 (1981) and under Good Laboratory Practice.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Remarks:
(Ciba-Geigy Limited, Experimental Toxicology GU 2.1, 4332 Stein/Switzerland)

Test material

Constituent 1
Chemical structure
Reference substance name:
2,6-di-tert-butyl-α-dimethylamino-p-cresol
EC Number:
201-816-1
EC Name:
2,6-di-tert-butyl-α-dimethylamino-p-cresol
Cas Number:
88-27-7
Molecular formula:
C17H29NO
IUPAC Name:
2,6-di-tert-butyl-4-[(dimethylamino)methyl]phenol
Details on test material:
- Physical state: solid
- purity: commercial grade

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Haedorin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12-14 weeks
- Weight at study initiation: 2-3 kg
- Housing: individually in metal cages
- Diet: ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: ad libitum
- Acclimation period: 5 days

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

IN-LIFE DATES: December 4, 1984 - December 7, 1984

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: the patches were moistened with water
Controls:
other: The contralateral flank treated with a control gauze patch served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
3 days
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: flank
- Type of wrap if used: gauze patch covered with an occlusive membrane and held in place by an adhesive tape.

SCORING SYSTEM: according to the grading scheme given in OECD guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.1
Reversibility:
fully reversible within: 24 hours (2/3 animals), 48 hours (1/3 animals)
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Irritant / corrosive response data:
Minimal formation of erythema was observed in all three animals (score = 1), reversible within 48 hours the latest. All scores for edema were zero at all time points.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions employed the test substance induced erythema reactions below the regulatory threshold of significance, therefore, the test article is considered to be not irritating.