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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Test performed according to proposed guideline, no details of test material purity. This substance differs in structure in a tertiary-butyl group in ortho position to the phenolic hydroxygroup and has a very similar toxicity profile. It is therefore considered adequate for read-across purposes.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Proposed Guidelines of the US EPA 40CFR 163.81-5 'Primary dermal irritation study'
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
more stringent exposure conditions (24h onto abraded and non-abraded skin)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Bumetrizole
EC Number:
223-445-4
EC Name:
Bumetrizole
Cas Number:
3896-11-5
Molecular formula:
C17 H18 Cl N3 O
IUPAC Name:
2-tert-butyl-6-(5-chloro-2H-benzotriazol-2-yl)-4-methylphenol
Details on test material:
- Name of test material (as cited in study report): TK 10048

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ivanovas, 7964 Kisslegg/Allgau, Germany; Madoerin AG, 4414 Fullinsdorf, Switzerland)
- Age at study initiation: adult
- Weight at study initiation: 2-3 kg
- Housing: individually in metal cages
- Diet (e.g. ad libitum): NAFAG No. 814 (Gossau AG) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 4 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2 deg C
- Humidity (%): 55+/-10 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 14 h dark/ 10 h light

Test system

Type of coverage:
occlusive
Preparation of test site:
other: both sides shaved, one side abraded
Vehicle:
other: propylene glycol:saline (70:30)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 50 % w/w

Duration of treatment / exposure:
24 h
Observation period:
7 days
Number of animals:
6 (3 per sex)
Details on study design:
TEST SITE
- Area of exposure: 2.5x2.5 cm
- % coverage: no data
- Type of wrap if used: gauze patches covered with an impermeable material and fastened to the body with adhesive tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 h


SCORING SYSTEM:
Skin reaction Value

Erythema and eschar formation:

No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight
eschar formations (injuries in depth) 4

Edema formation:

No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by
definite raising) 2
Moderate edema (raised approximately 1 millimeter) 3
Severe edema (raised more than 1 millimeter
and extending beyond the area of exposure) 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h
Score:
1.16
Max. score:
2
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: At 48h, only one animal had an erythema. Values for non-abraded skin.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h
Score:
0.16
Max. score:
1
Reversibility:
fully reversible within: 48h
Remarks on result:
other: values for non-abraded skin.
Other effects:
For abraded skin, almost identical scores were recorded.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU