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
Study period:
Oct. 22, 1979 to Nov. 12, 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
light/dark cycle, observation times, exposure time and the use of both intact and abraded skin.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)propionate]
EC Number:
253-039-2
EC Name:
Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)propionate]
Cas Number:
36443-68-2
Molecular formula:
C34H50O8
IUPAC Name:
ethane-1,2-diylbis(oxyethane-2,1-diyl) bis[3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propanoate]

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ciba-Geigy Limited (Toxicology GU 2.1)
- Weight at study initiation: 2 to 3 kgs
- Housing: Individually in metal cages
- Diet (e.g. ad libitum): ad libitum standard rabbit food NAFAG No. 814
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 days


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

Test system

Type of coverage:
occlusive
Preparation of test site:
other: Abraded and intact shaved
Vehicle:
other: Propylene glycol and saline (70:30)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Concentration (if solution): 50%
- amount: 0.5 g
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
3 males and 3 females
Details on study design:
TEST SITE
- Area of exposure: 2.5 X 2.5 cm
- Type of wrap if used: impermeable material

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours

SCORING SYSTEM:
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 formation (injuries in depth) = 4
Total possible erythema score = 4
Edema formation
No edema = 0
Very slight edema (barely perceptible) = 1
Slight edema (edges of area well defined bydefinite raising) = 2
Moderate edema (raised approximately 1 mm) = 3
Severe edema (raised more than 1 mm and extending beyond area of exposure) = 4
Total possible edema score = 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
4
Remarks on result:
other: for both intact and abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
4
Remarks on result:
other: for both intact and abraded skin
Irritant / corrosive response data:
No erythema or edema was observed on any of the test animals on abraded or intact skin.
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the present experiment the test article was found to cause no irritation when applied to intact and abraded rabbit skin.
Executive summary:

In a skin irritation study predating GLP the test substance was investigated for dermal effects in rabbits in a test similar to OECD testing guideline 404. An amount of 0.5 g test material was applied to the skin of 3 male and 3 female adult New Zealand White rabbits in an occlusive manner. The protocol differed by additional testing of abraded skin versus intact skin and a prolonged exposure time of 24h was used. Observation was terminated after 7 days which is acceptable as no indication of erythema or erythema was observed during the observation period. All scores for edema and erythema were zero at any time point. Based on the results of this study, the test article is considered to be not irritating to the rabbit skin.

Categories Display