Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test performed according to proposed guideline
Remarks:
Incomplete characteriszation of the test substance e.g. no details on test material purity

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 § 163.81-5 'Primary dermal irritation study' (1978-08-22)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(occlusive treatment, 24 h exposure duration)
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
Test material form:
solid
Specific details on test material used for the study:
- Name of test material (as cited in study report): TK 10048
- Physical appearance: yellow powder

Test animals

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

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 14 / 10

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved (one side abraded, other side intact)
Vehicle:
other: propylene glycol : saline (70 : 30)
Controls:
other: untreated site served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g
- Concentration: 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: 2.5 x 2.5 cm
- 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: no data

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #3, #4, #5, respectively
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: mean over 24, 48 and 72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of all animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
#1, #2, #3, #4, #5, respectively
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: mean over 24, 48 and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
of all animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0.06
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: intact skin
Other effects:
Scores for abraded skin were not taken into account for evaluation.

Any other information on results incl. tables

Table 1: Results from abraded skin.

 

Animal 1

Animal 2

Animal 3

Animal 4

Animal 5

Animal 6

 

Er

Ed

Er

Ed

Er

Ed

Er

Ed

Er

Ed

Er

Ed

24 hours

1

0

1

0

1

0

2

1

1

0

1

0

48 hours

0

0

0

0

0

0

1

0

0

0

0

0

72 hours

0

0

0

0

0

0

0

0

0

0

0

0

7 day

0

0

0

0

0

0

0

0

0

0

0

0

Er = Erythema

Ed = Edema

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met