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EC number: 939-616-8 | CAS number: 68391-03-7
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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- Toxicological Summary
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- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
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- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data

Skin irritation / corrosion
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Quaternary ammonium compounds, coco alkyltrimethyl, chlorides
- EC Number:
- 263-038-9
- EC Name:
- Quaternary ammonium compounds, coco alkyltrimethyl, chlorides
- Cas Number:
- 61789-18-2
- Molecular formula:
- C(n+3) H(2n+10) N Cl (n=8-18)
- IUPAC Name:
- Quaternary ammonium compounds, cocoalkyl trimethyl, chloride
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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 hours
- Score:
- 5.6
- Max. score:
- 8
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: severely irritating (due to not completely reversible reactions (moderate irritation was still present in one rabbit); in addition desquamation was noted on all sites late in the study period and fissuring was present on two sites
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 2.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 2.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 d
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 2.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- ca. 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- ca. 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- ca. 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 3.6
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 d
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 1.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- ca. 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- ca. 3.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- ca. 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- probability of moderate irritation
- Irritant / corrosive response data:
- Average erythema score for all animals at 24h: 3; 48h: 3; 72h: 2.8
Average edema score for all animals at 24h: 3.2; 48h: 2.8; 72h: 2.2
Reversibility: Yes, the highest levels of irritation occurred two to three days after dosing and irritation subsequently decreased although moderate reactions still persisted in one animal after study Day 12.
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 (score: erythema:2; edema:1) 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.
Result details
Table 1: Table for skin irritation study |
||||
score (average animals investigated) |
time |
Erythema |
Edema |
|
average score |
< 1 hr After exposure |
2.6 |
1.5 |
|
24 h |
3 |
3.2 |
||
48 h |
3 |
2.8 |
||
72 h |
2.8 |
2.2 |
||
other times |
State time |
|
|
|
average score |
24h, 48h, 72h |
3.0 |
2.7 |
|
reversibility: * |
n.c |
n.c |
||
Average time for reversibility |
|
|
||
* c : completely reversible |
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 1C (corrosive) based on CLP criteria
- Conclusions:
- Under the study conditions, the test substance (containing 33% a.i.) was found to be severly irritating to rabbit skin; therefore, 100% Coco TMAC can be considered to be corrosive.
- Executive summary:
A study was conducted to determine the skin irritation potential of the test substance, Coco TMAC (33% active in water), in New Zealand White rabbits according to OECD 404 Guideline, in compliance with GLP. Six animals were treated with 0.5 mL undiluted test substance (33%) in a semi-occlusive patch (1” X 1” gauze) that was overwrapped with a gauze binder and secured with dermiform tape. Plastic restraint collars were applied and remained on the animals for the duration of the 4 h exposure period, after which the tape and test substance were removed. The Draize classification scoring criteria was used to evaluate the irritation potential. Application sites were observed for erythema and oedema at 4, 24, 48 and 72 h after exposure and then daily up to 14 d. The test substance induced moderate erythema and moderate to severe edema on all sites. Remission of irritation signs occurred as the study progressed, however, moderate irritation was still present in one rabbit after study Day 12 (erythema: 2 ‘slight’; edema:1 ‘barely perceptible’). In addition, desquamation was noted on all sites late in the study period and fissuring was present on two sites. The Primary Irritation Index was calculated to be 5.6 (indicative of moderate irritation). Under the study conditions, due to persistence of irritation reactions in one animal as well as desquamation on all sites and fissuring on 2 sites, the test substance is considered to be severely irritating. Under the study conditions, the test substance (containing 33% a.i.) was found to be severly irritating to rabbit skin; therefore, 100% Coco TMAC can be considered to be corrosive (Naas, 1988).
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