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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to the Test Guidelines described in the EEC Directive 84/449/EEC.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3',5'-dichloro-4'-ethyl-2'-hydroxypalmitanilide
EC Number:
406-200-8
EC Name:
3',5'-dichloro-4'-ethyl-2'-hydroxypalmitanilide
Cas Number:
117827-06-2
Molecular formula:
C24H39Cl2NO2
IUPAC Name:
N-(3,5-dichloro-4-ethyl-2-hydroxyphenyl)hexadecanamide
Details on test material:
Identification : UC—136
Description : White powder
Batch number : Unknown
Purity : 98.5%
Instructions for test article storage : At room temperature in the dark in a tightly sealed container
Stability of test : substance Stable for one year maximal under storage conditions
Stability of test article in vehicle : Unknown
Safety precautions : Gloves, goggles and face mask were sufficient to ensure personnel health and safety.

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Original Source : Charles River Wiga, Sulzfeld, West—Germany.
Total number of animals : 3 females
Age at start of treatment : Approx. 14 weeks
Body weight at start of treatment : 2533 — 2936 gram
Identification : Ear tag.
Acclimatisatjon : At least five days under test conditions.
HUSBANDRY
Room No.: 9
Conditions : Standard Laboratory Conditions. Air—conditioned with 7.5—15 air changes per
hour and hourly monitored environment with temperature 21 ± 3°C and relative ~ humidity 30—88%,
12 hours artificial fluorescent light / 12 hours dark.
Accommodation : Individually in cages with perforated floors equipped with an automatic
drinking system (ITL, Bergen / The Netherlands).
Diet : Standard laboratory rabbit diet (LKK—20, pellet diameter 4mm, Hope Farms,
Woerden I The Netherlands) approx. 100 gram per day. Certificates of analysis
are retained in the RCC NOTOX archives.
Water : Free access to tap—water diluted with decalcified water. Certificates of
analysis of tap—water are retained in the RCC NOTOX archives.
Duration of treatment / exposure:
4 hours.
Observation period:
72 hours
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 60 minutes
Score:
0
Max. score:
0
Reversibility:
no data
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
0
Reversibility:
no data
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
0
Reversibility:
no data
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
0
Reversibility:
no data
Irritant / corrosive response data:
No skin irritation was observed.
No corrosive effect was evident on the skin.
Other effects:
In the area of application no staining of the treated skin by the test substance was observed.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
UC—136 resulted in a primary irritation index of 0 (non—irritating) when
applied to the intact rabbit skin.