[No public or meaningful name is available]

Skin irritation / corrosion

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:

guideline study with acceptable restrictions

Remarks:

Study not GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

N,N,N-trimethyl-C12-14 (even numbered)-alkyl-1-aminium chloride

Molecular formula:

C15H34Cl1N1 (representative molecular formula of C12 chain)

IUPAC Name:

N,N,N-trimethyl-C12-14 (even numbered)-alkyl-1-aminium chloride

Constituent 2

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

Dihydrogen oxide

Test material form:

liquid

Specific details on test material used for the study:

- Präpagen 2916 (Hoe S 2916)
- Composition: ca. 40% C12-14 alkylmethylammonium chloride, ca. 1% amine/aminehydrochloride with mentioned C chain, ca. 1% salt, ca. 60% water
- Form: Clear liquid
- Storage: in the dark at 2°C

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, conventional breeding
- Weight at study initiation: 2.0 - 2.3 kg
- Housing: individual cages in climatised room
- Diet (e.g. ad libitum): ERKA Z 6000 (Robert Koch oHG, Germany)
- Water (e.g. ad libitum): deinosed chlorinated water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

Undiluted

Duration of treatment / exposure:

4 h

Observation period:

14 d

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 20 cm2
- Type of wrap if used: Hansamed bandage and semi-occlusive wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): careful removal of remaining test substance after exposure period
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
(indicate if minutes, hours or days): 0.5-1, 24, 48 and 72 h then 7 and 14 d after patch removal

SCORING SYSTEM:
- Method of calculation: as per OECD guideline

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 2.53

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 1.67

Max. score:

4

Reversibility:

fully reversible within: 14 d

Remarks on result:

probability of mild irritation

Irritant / corrosive response data:

After the 4 h exposure period, moderate to severe erythema gradually developped, leading in part to the appearance of scabs after 48 h. There was pronounced edema in all animals. Seven days after application, the treated skin was hardened. Large and small detachments were seen. In 4 out of 6 animals, scars remained on the skin.

Any other information on results incl. tables

Individual results are presented in the attachment entitled 'Präpagen skin irritation results'.

Applicant's summary and conclusion

Interpretation of results:

other: Category 1C (corrosive) based on CLP criteria

Conclusions:

Under the study conditions, the test substance was considered to be irritating to skin. Considering the results obtained with the test substance containing 40% of the a.i. along with the evidence from a study with read across substance, Coco TMAC, it is proposed that 100% C12-14 TMAC can be considered to be corrosive to rabbit skin.

Executive summary:

A study was conducted to determine the skin irritation potential of the test substance, C12-14 TMAC (active ingredient 40%), in rabbit, according to OECD 404 Guideline. Six New Zealand White rabbits were exposed to undiluted substance (i.e., 40% test substance) on their shaved flank. The exposure period was 4 h, using a Hansplast patch and semi-occlusive bandaging. After 4 h, remaining test substance was carefully removed. The treated skin area was observed after 0.5-1, 24, 48 and 72 h then 7 and 14 d. After the 4 h exposure period, moderate to severe erythema gradually developped, leading in part to the appearance of scabs after 48 h. There was pronounced edema in all animals. Seven days after application, the treated skin was hardened. Large and small detachments were seen. In 4 out of 6 animals, scars remained on the skin. Based on the strong effects observed (scarring), the test substance was considered to be irritating to skin (Jung and Weigand, 1982). Considering the results obtained with the test substance containing 40% of the a.i. along with the evidence from a study with read across substance, Coco TMAC, it is proposed that 100% C12-14 TMAC can be considered to be corrosive to rabbit skin.