Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions (non-GLP, 24-hour occlusive exposure, TS conc. 50% in vehicle)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EPA guideline (§ 163.81-5 "Primary dermal irritation study". Federal Register, Vol. 43, No. 163, August 22, 1978)
GLP compliance:
no
Remarks:
pre-GLP

Test material

Constituent 1
Reference substance name:
FAT 11178/B
IUPAC Name:
FAT 11178/B
Details on test material:
- Name of test material (as cited in study report): FAT 11178/B
- Physical appearance: red powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Exp. Toxicology Sisseln, CIBA-Geigy Ltd.
- Age at study initiation: adult animals
- Weight at study initiation: 2 - 3 kg
- Housing: single housing in metal cages
- Diet: standard rabbit food ad libitum (NAFAG, No. 814, Gossau SG)
- Water: ad libitum
- Acclimation period: at least 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 intact and scarified skin
Vehicle:
other: polyethylene glycol (PEG 400) + saline 0.9 % (70 : 30 parts)
Controls:
other: untreated skin of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g
- Concentration: 50%
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
6 (3 males + 3 females)
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm on back and flank
- Type of wrap if used: impermeable

SCORING SYSTEM: according to Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
No irritant response data after a 24-hours occlusive exposure to intact skin. Grade 1 edema was noted after 24 and 48 h for some animals with abraded skin.

Any other information on results incl. tables

Individual cutaneous examinations and mean values (24-hour exposure, occlusive, intact skin):

Readings

Animal

Exposure period: 24 h, occlusive

Erythema

Edema

24 h

01

0

0

02

0

0

03

0

0

04

0

0

05

0

0

06

0

0

48 h

01

0

0

02

0

0

03

0

0

04

0

0

05

0

0

06

0

0

72 h

01

0

0

02

0

0

03

0

0

04

0

0

05

0

0

06

0

0

Mean

(24, 48, 72 h)

01

0

0

02

0

0

03

0

0

04

0

0

05

0

0

06

0

0

Mean

(24, 48, 72 h)

 

0.0

0.0

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
The test material is not irritating to the rabbit skin.
Executive summary:

The test item contained 89% active ingredient and 10% urea and was applied at a concentration of 50% in vehicle (propylene glycol and saline, 70:30 parts). Three male and female New Zealand rabbits were shaved on the back. The left side was abraded. Gauze patches of 6.25 cm² were loaded with 0.5 g of the test item. Both the abraded and non abraded sites were treated and covered with an impermeable material for 24h. The skin irritation was assessed after 1, 2, 3, 4 and 7 days. Grade 1 edema was noted after 24 and 48 h for some animals with abraded skin only. Erythema could not be assessed due to the coloration by the dye.

Categories Display