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Diss Factsheets

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:
June 22 - July 20 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study conducted according to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Alcohols, C6-24 and C6-24-unsatd., distn. residues
EC Number:
310-079-6
EC Name:
Alcohols, C6-24 and C6-24-unsatd., distn. residues
Cas Number:
102242-48-8
Molecular formula:
Not available due to the complexity of the substance
IUPAC Name:
Alcohols, C6-24 and C6-24-unsatd. even numbered, distn. residues
Details on test material:
- Name of test material (as cited in study report): Pernil RU, Espum EGA 213
- Chemical designation: 18:1 fatty alkohol, unsaturated, distillation residue
- Physical state: brown liquid
- Analytical purity: 100%
- Lot/batch No.: Charge of laboratory, no batch number given
- Expiration date: December 31, 1995
- Stability: yes
- Storage: at room temperature

Test animals

Species:
rabbit
Strain:
other: Kleinrussen, CHbb:HM
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Thomae GmbH, Biberach, Germany
- Age at study initiation: approx. 17 months
- Weight at study initiation: approx. 2.73 kg
- Housing: individually
- Diet: Ssniff rabbit diet K4 (Ssniff GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Air changes: 8/h
- Photoperiod (hrs dark / hrs light): 12 h/ 12 h
- Other: music was offered during light hours

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: approximatively 24 hours prior application, the fur of the rabbits was clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin areas of the test animals served for control
Amount / concentration applied:
The application volume of the unchanged test material was about 0.5 mL.
Duration of treatment / exposure:
4 hour(s)
Observation period:
14 days (2 animals) and 21 days (one animal)
Reading time points: 1, 24, 48, 72 h
Number of animals:
3 males
Details on study design:
TEST SITE
- The chosen application site (2.5 cm x 2.5 cm) was located on the left flank of each animal;
- An amount of 0.5 mL of the test item was applied onto the clipped skin of each animals and the application site was covered with a semi occlusive dressing.

REMOVAL OF TEST SUBSTANCE
- The exposure period was 4 hours;
- Following removal of the dressing, the application site was cleaned from residual test material using tap water.

SCORING SYSTEM
- The assessment of the findings was based on the Draize Scoring System, as recommended by the current testing guideline (Draize JH, Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. In Dermal Toxicity, 46-59, 1959).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: erythema graded 1 still was seen after 21 days; after this time point, an intense hair growth was noticed.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: at day 7, eschar formation and brownish discolouration were evident; at day 14, no more effects were seen.
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: at day 7, eschar formation was evident; at day 14, no more effects were seen.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of 3 animals
Time point:
24/48/72 h
Score:
1.6
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: in fact, in 2/3 animals full reversibility was achieved after 14 days whereas in the third animal, erythema still was evident after 21 days.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: edema graded 1 still was seen after 21 days; after this time point, an intense hair growth was noticed.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: at day 7, eschar formation and brownish discolouration were evident; at day 14, no more effects were seen.
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: at day 7, eschar formation was evident; at day 14, no more effects were seen.
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of 3 animals
Time point:
24/48/72 h
Score:
1.6
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: in fact, in 2/3 animals full reversibility was achieved after 14 days whereas in the third animal, edema still was evident after 21 days.
Irritant / corrosive response data:
- At reading time point 1 h, all 3 animals displayed erythema and edema ranging from grade 1 to 2.
- At reading time point 24 h, one animal displayed erythema and edema of grade 3, respectively; furthermore, the animal showed brownish discolouration. The 2 remaining animals showed erythema and edema not exceeding grade 2 in severity; no discolouration was observed.
- At reading time point 48 h, the first animal still displayed skin reaction as described for 24 h. One of the 2 remaining animals showed erythema and edema of grade 1, respectively, whereas the second animal only showed erythema.
- At reading time point 72 h, the first animal still displayed skin reaction as described for 24 and 48 h. Both remaining animals showed erythema and edema of grade 1.
- At reading time point day 7, no reversibility could be evidenced in any of the 3 animals. They all showed eschar formation; the first animal also showed a small shiny trip whereas another animal showed brownish discolouration.
- At reading time point 14 day, the first animal with the more severe findings still showed skin reaction as seen after 7 days, except for eschar. In contrast, full reversibility was achieved in the 2 remaining animals.
- At reading time point 21 day, the one animal with the more severe findings still showed erythema and edema graded 1, respectively. Thus, for this case full reversibility could not be achieved during the observation of 21 days.
Other effects:
In the animal which showed the most severe skin reaction, an intense hair growth was noticed after ending of the 21 day observation period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified