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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:
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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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

Resultsopen allclose all
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
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.