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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
the duration of treatment was 4 hours
Observation period:
reaction was evaluated approx. 30-60 minutes and 24, 48 and 72 hours after the end of exposure period; additionally after 7 days
Number of animals:
3 animals
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: the substance was placed on 2.5 x 2.5 cm squares of surgical gauze and applied to the corresponding test area. The resulting patches were held close to the body using strips of adhesive tape. Finally, a strip of gauze was wrapped around the trunk of the animal and fixed to the body using additional adhesive tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing

SCORING SYSTEM: according to Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #3
Time point:
other: mean 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean 24, 48 and 72 hours
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
In the examinations carried out in the first 60 minutes and 24 hours, all the animals showed well defined erythema (grade 2). In addition, slight edema (grade 2) appeared in two of them and moderate edema (grade 3) in the remaining animal. 48 and 72 hours after treatment, all the animals continued to show well defined erythema (grade 2), while the edema was subsiding.
In an additional reading carried out on day 7 after treatment, the skin alteration observed in the previous readings had totally disappeared, only dryness of the skin was observed in all the animals.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
Conclusions:
Classification is based on erythema/eschar and oedema calculated as mean scores following grading at 24, 48 and 72 hours after removal of the test material, in consideration of reversibility.
No classification for skin irritation is justified for the oleic acid-based TEA-Esterquat according to CLP, EU GHS (Regulation (EC) No 1272/2008).
Wheareas classification is required for TETRANYL AOT-1 according to Directive 67/548/EEC.
Executive summary:

In a primary dermal irritation study according to OECD Guideline 404 1992, three White New Zealand rabbits were semi-occlusive dermally exposed to 0.5 mL of the oleic acid-based TEA-Esterquat (80 % a.i. and 20 % DPG) for 4 hours to approximately 6 cm² of body surface area. Animals then were observed for 7 days. Irritation was scored by the method of Draize as stipulated by OECD Guideline 404.

In the examinations carried out in the first 60 minutes and 24 hours, all the animals showed well defined erythema (grade 2). In addition, slight edema (grade 2) appeared in two of them and moderate edema (grade 3) in the remaining animal. 48 and 72 hours after treatment, all the animals continued to show well defined erythema (grade 2), while the edema was subsiding. Effects were fully reversible at day 7 after treatment.