Quaternary ammonium compounds, bis(C16-18 and C18-unsatd. alkyl)dimethyl, chlorides

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study according to GLP

Cross-reference

Reason / purpose for cross-reference:

read-across source

Reference

Endpoint:

acute toxicity: dermal

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

For details on endpoint specific justification please see read-across report in section 13 or find a link in cross-reference “assessment report”.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

assessment report

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortalitiy througout study period

Clinical signs:

other: no clinical signs throughout study period

Gross pathology:

no abnormalities

Other findings:

- Organ weights: no data
- Histopathology: not performed
- Potential target organs: no target identified
- Other observations: none

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the test item was greater 2000 mg/kg body weight in rats. Based hereupon the test material is considered to be acutely non-toxic and thus labelling and classification is not required.

Executive summary:

The study used as source investigated acute dermal toxicity .The study results of the source compound were considered applicable to the target compound. Justification and applicability of the read-across approach (structural analogue) is outlined in the read-across report in section 13 or find a link in cross reference “assessment report”.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Quaternary ammonium compounds, bis(hydrogenated tallow alkyl)dimethyl, chlorides

EC Number:

263-090-2

EC Name:

Quaternary ammonium compounds, bis(hydrogenated tallow alkyl)dimethyl, chlorides

Cas Number:

61789-80-8

Molecular formula:

R2Me2N(+)Cl(-) whereas R = mainly C16, 18-alkyl molecular weight range is based on R=14 (lower limit value) and R=18 (higher limit value)

IUPAC Name:

N,N-Dimethyl-N,N-di-n-alkyl(C16-18)-ammoniumchloride

Details on test material:

- Name of test material (as cited in study report): Praepagen WK Hochkonz.
- Physical state: waxlike solid
- Analytical purity: approximately 97% active, 3% water
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: see above
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: EO6116501, dated May 4, 1984
- Expiration date of the lot/batch: May 1989
- Radiochemical purity (if radiolabelling): n.a.
- Specific activity (if radiolabelling): n.a.
- Locations of the label (if radiolabelling): n.a.
- Expiration date of radiochemical substance (if radiolabelling): n.a.
- Stability under test conditions: stable
- Storage condition of test material: darkness, room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River France
- Age at study initiation: approximately 9 weeks
- Weight at study initiation: males: 281 +/- 5 g; females: 221 +/- 6 g
- Fasting period before study: no
- Housing: polypropylene cages (one animal per cage)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): 12 per hour
- Photoperiod (hrs dark / hrs light): 12 hours periodically

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: 5 x 7 cm
- % coverage: approximately 10% of body surface
- Type of wrap if used: gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
- Concentration (if solution): n.a.
- Constant volume or concentration used: n.a.
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): water
- Concentration (if solution): n.a.
- Lot/batch no. (if required): n.a.
- Purity: n.a.

Duration of exposure:

24 hours

Doses:

2000 mg/kg body weight (limit dose)

No. of animals per sex per dose:

5 male; 5 female

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

n.a.

Results and discussion

Preliminary study:

n.a.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortalitiy througout study period

Clinical signs:

other: no clinical signs throughout study period

Gross pathology:

no abnormalities

Other findings:

- Organ weights: no data
- Histopathology: not performed
- Potential target organs: no target identified
- Other observations: none

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of Praepagen WK hochkonz was greater 2000 mg/kg body weight in rats. Based hereupon the test material is considered to be acutely non-toxic and thus labelling and classification is not required.

Executive summary:

The acute dermal toxicity of the test compound Praepagen WK hochkonz (dihydrogenated tallowalkyldimethyl ammonium chloride, purity approximately 97%) was investigated in rats according to OECD Test Guideline 402 in compliance with the principles of GLP. The test substance was applied as an aqueous suspension to the shaved skin of 5 male and 5 female animals at a dose level of 2000 mg/kg body weight (limit dose) under occlusive conditions. Mortality, general behaviour, clinical signs and body weight development were recorded daily for an observation period of 14 days. A necropsy was performed on each animal sacrificed at the end of the study. There was no mortality throughout the study period at the dose level of 2000 mg/kg body weight tested. General behaviour and bodyweight of the animals were not influenced by the treatment. Clinical signs of significance were not observed. Skin dryness was noted after the removal of the dressing up to day 6 in all animals. Additional signs of skin irritation were not observed. The macroscopic examination of the main organs did not reveal abnormalities in any of the animals sacrificed at the end of the observation period. Based on the study results, the median lethal dose (LD50) of the test substance Praepagen WK hochkonz when administered dermally to rats is greater than 2000 mg/kg body weight. Additionally, at this dose level the test material Praepagen WK hochkonz did not induce any signs of toxicity.