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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May - June 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Type:
impurity
Type:
impurity
Type:
impurity
Test material form:
solid
Specific details on test material used for the study:
Information from study report:
- Name of test material: Emulgator E30, Fest
- CAS number: 5896-54-8
The CAS number in report (5896-54-8) is misleading, since this CAS number does only represent 1-Penta-decanesulfonic acid, sodium salt (1:1), but it is confirmed that the substance used is correctly assigned to CAS 68188-18-1.
- Appearance/Further information: The test substance was supplied as white wax-like leaf-let and was received at the test institute on March 06, 1991.
- Batch No. of test material: 210291
- Purity: 95 %
- Analysis reference: TGL 39237

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: NZW rabbits
- Sex: male
- Source: Thomae, Biberach, Germany
- Weight at study initiation (mean): 2.5 kg ± 0.047
- Housing: singly in steel wire cages
- Diet and water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 28 - 41
- Air changes (per hr): 12-15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
500 g
Duration of treatment / exposure:
4 h
Observation period:
14 days
Number of animals:
3
Details on study design:
One day before the application the fur was carefully removed by shaving an area approximately 10 x 20 cm of the dorsal trunk.
On day of application 0.5 g of the test substance was placed on a 2 x 3 cm gauze patch and wetted for one hour with 0.4 mL water (Ampuwa, Fresenius, Bad Homburg) to make the emulgator soft. This patch was then positioned on the rabbit so that the test substance was in contact with the shaved skin, just left of the dorsal midline. The patch was held in place by a wrapping of gauze which was secured and semioccluded by a wrapping of blendderm and Leukoplast. After a 4-hour exposure period, wrappings were removed and the test substance was gently washed away with water.

SCORING SYSTEM: Draize
The treated area was scored 0.5, 1, 6, 24, 48, and 72 hours after patch removal, and then periodically until day 14.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 2 - <= 3
Max. score:
4
Reversibility:
not fully reversible within: 14 days. A slight redness(score 1) was still present by Day 14.
Remarks on result:
other: mean score: 2.7; at 48 and 72 h leathery and red skin was reported
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 12 days
Remarks on result:
other: at 48 and 72 h leathery and red skin was reported
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 2 - <= 3
Max. score:
4
Reversibility:
fully reversible within: 12 days
Remarks on result:
other: mean score: 2.7; at 72 h leathery skin was reported
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Remarks on result:
other: mean score: 0.3
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Remarks on result:
other: mean score: 0.7
Irritant / corrosive response data:
The substance caused initial slight to mild erythema of the treated skin, progressing to moderate erythema in all rabbits by 48 hours after treatment. The severity of the redness decreased slowly thereafter, but was in one animal still present as a slight redness by study day 14. All rabbits also exhibited slight to mild oedema during the first four days.
Other effects:
No animal died during the observation period of 14 days. In all animals, the body weight development was apparently normal, unaffected by treatment. No adverse clinical observations were made in any animal. At necropsy, all animals were essentially normal.

Applicant's summary and conclusion

Executive summary:

In a skin irritation/corrosion study according to OECD TG 404 the test substance was applied under semiocclusive dressings for 4 hours to the previously shorn skin of three male rabbits. The treated areas were assessed after 0.5, 1, 6, 24, 48, and 72 hours and then periodically until Day 14 using the Draize scale. The substance caused local irritation of exposed skin, but no evidence of systemic toxicity. In detail, the substance caused initial slight to mild erythema of the treated skin, progressing to moderate erythema in all rabbits by 48 hours after treatment. Additionally for some time points leathery and red skin was reported. The severity of the redness decreased slowly thereafter, but was still present in one animal as a slight redness by study day 14. All rabbits also exhibited slight to mild oedema during the first four days. Mean erythema scores after 24, 48 and 72 hours were 3 (1/3 rabbits) and 2.7 (2/3 rabbits), mean edema scores were 0, 1.3, and 1.7 (each 1/3).