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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
18/06/1997-21/06/1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to current OECD guideline and in compliance with GLP. The study is a read across from 1-docosanol (CAS 661-19-8).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Docosan-1-ol
EC Number:
211-546-6
EC Name:
Docosan-1-ol
Cas Number:
661-19-8
Molecular formula:
C22H46O
IUPAC Name:
docosan-1-ol
Details on test material:
- Name of test material (as cited in study report): Kalcol 220-80

- Physical state: white solid

- Storage condition of test material: ambient temperature (<25C) in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.81 - 3.15 kg
- Housing:individually housed in suspended metal cages
- Diet: STANRAB SQC Rabbit diet, ad libitum
- Water: mains water, ad libitum
- Acclimation period:minimum 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-20
- Humidity (%): 59-62
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

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 of test material was moistened with 0.5ml distilled water



Duration of treatment / exposure:
4 hour(s)
Observation period:
Ca. 1h, 24h, 48h, 72h after patch removal
Number of animals:
3F
Details on study design:
TEST SITE
- Area of exposure: shorn dorsal  surface of the skin,  2.5 x 2.5 cm
- Type of wrap if used: gauze patch secured in position with a strip of surgical adhesive tape, wrapped in an elastic corset.


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: 4h


SCORING SYSTEM: Draize

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24/48/72h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Irritant / corrosive response data:
The test material produced a primary irritation index of 0.0. 
Other effects:
No evidence of skin irritation was noted during the study other than very slight  erythema at one test site at 1 hour after patch removal. All other scores  were 0.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Kalcol 220-80 is not a skin irritant when applied to rabbit skin undiluted in a 4 hour semi-occlusive exposure. Group mean 24+48+72 hours were 0.
The result is a read across from 1-docosanol (CAS 661-19-8).