Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 23 February, 1988 to 8 March, 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed according to the method equivalent to the OECD guideline 404.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Identification: Quaternary ammonium salt
- Lot No.: 1735305
- Date received: February 10, 1988
- Physical description: Clear yellow liquid
- Storage conditions: Sealed container at room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Mohican Valley Rabbitry; Loudonville, Ohio
- Age at study initiation: Young adult
- Weight at study initiation: 2,736 to 3,450 g at study initiation
- Housing: Individual suspended wire-mesh cages. The animals were maintained in accordance with the recommendations contained in the "guide for care and use of laboratory animals" NIH publication, No. 85023.
- Diet: Purina Certified Rabbit Chow #5322
- Water: Tap water
- Acclimation period: 7 d

ENVIRONMENTAL CONDITIONS
- Temperature : 71-74 °F
- Humidity (%): 50-74%
- Photoperiod (hrs dark / hrs light): 12 h light/12 h dark

IN-LIFE DATES: From: 23 February, 1988 to 8 March, 1988

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL/site
Duration of treatment / exposure:
4 h
Observation period:
14 d
Number of animals:
3 males and 3 females
Details on study design:
TEST SITE
0.5 mL dose was applied under secured 1 x 1 inch2 guaze patches that were overwrapped with a gauze binder secured with dermiform tape. Plastic restraint collars were applied and remained on the animals for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: At the end of 4 h, the collars and bandages were removed and the sites wiped with wet disposable paper towels.

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 h
Score:
5.6
Max. score:
8
Reversibility:
fully reversible within: 14 d
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
18
Reversibility:
fully reversible within: 14 d
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 h
Score:
17
Reversibility:
fully reversible within: 14 d
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h
Score:
19
Reversibility:
fully reversible within: 14 d
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 h
Score:
13
Reversibility:
fully reversible within: 14 d
Irritant / corrosive response data:
The test substance induced moderate erythema and moderate to severe oedema on all sites. Irritation decreased as the study progressed, however, moderate irritation was present in one rabbit through study Day 11.
Other effects:
Desquamation was noted on all sites late in the study period and fissuring was present on two sites.

Any other information on results incl. tables

Mortality: One rabbit was sacrificed in extremis on Day 3 due to broken back.

Body weight: No remarkable changes occurred.

Applicant's summary and conclusion

Interpretation of results:
Category 1C (corrosive)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, the test substance require a classification under Category 1C corrosive to skin according EC criteria (67/548/EEC) and CLP criteria (EC 1272/2008).
Executive summary:

A study similar to OECD guideline 404 was conducted to assess the skin irritation potential of C12-C18 TMAC (purity not mentioned) to rabbit skin. Six animals were treated with 0.5 mL undiluted test substance in a semi-occlusive patch (1” X 1” gauze) that was overwrapped with a gauze binder, secured with dermiform tape. Plastic restraint collars were applied and remained on the animals for the duration of the 4 hours followed by removal of the tape and test substance. The Draize classification scoring criteria was used for evaluating the corrosion potential. Application sites were observed for erythema and oedema at 4, 24, 48 and 72 hours after exposure. The primary irritation index was determined to be 5.6. Under the test conditions, C12-C18-TMAC was considered to be moderately irritating to rabbit skin (Nass DJ, 1988).