Registration Dossier

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:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
(3-chloro-2-hydroxypropyl)dimethyloctadecylammonium chloride
EC Number:
221-083-1
EC Name:
(3-chloro-2-hydroxypropyl)dimethyloctadecylammonium chloride
Cas Number:
3001-63-6
Molecular formula:
C23H49ClNO.Cl
IUPAC Name:
(3-chloro-2-hydroxypropyl)dimethyloctadecylazanium chloride
Constituent 2
Chemical structure
Reference substance name:
Propane-1,2-diol
EC Number:
200-338-0
EC Name:
Propane-1,2-diol
Cas Number:
57-55-6
Molecular formula:
C3H8O2
IUPAC Name:
propylene glycol
Test material form:
liquid
Details on test material:
Aqueous solution
Specific details on test material used for the study:
pH 5.85, Density: 0.99mg/l

Test animals

Species:
rabbit
Strain:
other: White Russian (albino)
Details on test animals or test system and environmental conditions:
Female rabbits. 5-6 months old, 2.1 - 2.5 kg. Acclimatization period before test: 1 day
Feeding: Standardized test animal feed, Hydration: water ad libitum, Room temperature: 22 C +/- 1C, Relative Humidity: 50 – 60%, Room lighting: 12 hours artificial lighting / 12 hs darkness, Room hygiene: Laboratory and cage cleaning by means of Customary antiseptics, And device disinfection by means of autoclave and hot air sterilizer.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved, intact and abraded
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
1 24, 48 and 72 hours after removal of the dressing, then up to 14 days follow up.
Number of animals:
3
Details on study design:
0.5 ml of the test product was absorbed in a cotton ball to ensure a reliable application to the back skin, which was shaved between the shoulder and the cross-leg region. The application site was covered with an approximately 6.25 sq-cm linen cloth, which adhered to a synthetic adhesive film. A circular occlusal dressing around the trunk. The contralateral areas differed from each other in that they existed on the left side from intact (intact) skin and on the right side from artificially injured (superficially abraded) skin. Two patches served to cover the test product (one each on an intact and scarified region), 2 untreated skin areas covered at appropriate sites. The exposure time was 4 hours. The skin texture was assessed after 1 24, 48 and 72 hours after removal of the dressing and evaluated according to a rating key quantitatively of 0-4. In the case of skin reactions, qualitative decision was made based on either erythema or eschar and oedema development.

Rating: The values determined at the above-mentioned examination times on the substance-treated skin areas for the erythema and scleral biopsy as well as the embedding were averaged and added by all animals, separately for the intact and scarified region.
Within the scope of this study, only the inconsistency of the mean values of the intact skin areas (8, cf. Table 1), divided by the number 4, was used for the determination of the degree of damage (primary stimulus index). The following assessment scheme was applied:

0.0 - 0.5 not irritating
0.6 - 3.0 slightly irritating
3.1 - 5.0 moderately irritating
5.1 - 8.0 strongly irritating

Results and discussion

In vivo

Results
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
2.1
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Irritant / corrosive response data:
A single application of 0.5 ml QUAB 426 to the intact back skin of the rabbit resulted in erythema of varying degrees of severity in all three test animals. The erythema received the evaluation grades 1 (very slight, hardly perceptible erythema), 2 (well-determinable erythema), and 3 (moderate to severe erythema). These erythemas lasted the 72-hour follow-up period. However, they were fully healed at the end of the 14-day follow-up period.
Oedemas occurred only in the above-mentioned. Very light with 2 out of 3 test animals from the 2nd and 3rd follow-up days. They were temporary and were no longer detectable on the 6th follow-up day.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The primary irritancy index was 2.1. which indicates the test material has slight irritating properties on the intact skin of the rabbit.