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EC number: 939-253-5 | CAS number: 68424-85-1
Repeated dose toxicity: other routes
Administrative data
- Endpoint:
- repeated dose toxicity: other route
- Type of information:
- other: Literature data
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Secondary literature.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Toxicity profile - benzalkonium chloride.
- Year:
- 1 989
- Bibliographic source:
- BIBRA, 1989
- Reference Type:
- publication
- Title:
- CIR: Final report on the safety assessment of benzalkonium chloride.
- Year:
- 1 989
- Bibliographic source:
- JACT 8(4):589-625, 1989.
- Reference Type:
- publication
- Title:
- Toxicology of cationic surfactants. In: cationic surfactants.
- Author:
- Cutler RA and Drobeck HP
- Year:
- 1 970
- Bibliographic source:
- Jungermann E (Ed.) Marcel Dekker, Inc., New York, Vol. 4 (Chap. 15).
Materials and methods
Test material
- Reference substance name:
- Quaternary ammonium compounds, benzyl C12-C16 (even numbered)-alkyldimethyl chlorides
- EC Number:
- 939-253-5
- Cas Number:
- 68424-85-1
- Molecular formula:
- C12-16H25-33-(CH3)2-C6H5-N.CL
- IUPAC Name:
- Quaternary ammonium compounds, benzyl C12-C16 (even numbered)-alkyldimethyl chlorides
- Reference substance name:
- Quaternary ammonium compounds, benzyl-C12-16-alkyldimethyl, chlorides
- EC Number:
- 270-325-2
- EC Name:
- Quaternary ammonium compounds, benzyl-C12-16-alkyldimethyl, chlorides
- Cas Number:
- 68424-85-1
- Molecular formula:
- Cn+9H2n+14N Cl (n=12-16)
- IUPAC Name:
- C12-C16 alkylbenzyldimethylammonium chloride (CAS# 68424-85-1)
- Reference substance name:
- Quaternary ammonium compounds, benzyl-C12-C16-alkyldimethyl, chloride (i.e., benzyl C12-16 alkyl dimethyl ammonium chloride)
- IUPAC Name:
- Quaternary ammonium compounds, benzyl-C12-C16-alkyldimethyl, chloride (i.e., benzyl C12-16 alkyl dimethyl ammonium chloride)
Constituent 1
Constituent 2
Constituent 3
Results and discussion
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Dermal:
Duration of study: 3 months, species: rat, dose level: 10 mg a.i./kg bw/d, 5 times/wk. Results: changes in the blood picture, liver and kidney damage, decreased growth, increased weight adrenals, kidney and testes.
Duration of study: 100 weeks, species: mice, dose level: 10 mg a.i./kg bw/d, 5 times/wk, open application. Results: Gross examination of major organs showed no adverse systemic effects.
Duration of study: 4 weeks / lifelong, species: rabbits, dose level: 4 weeks: 2 mg a.i./kg bw/d, 5 d/wk; lifelong: 1.7 mg a.i./kg bw/d, twice/wk; both uncovered application. Results: No adverse systemic effects.
Inhalation:
Toxicity by inhalation of vapour is not attainable at the saturated atmosphere that can be generated under ambient temperature conditions. An inhalation toxicity study of an aerosolized hair conditioner containing 0.2% of a 50.0% test solution (effective test concentration = 0.1%) was conducted in rats and Syrian Golden hamsters. The animals were exposed to the conditioner (9.9 mg/m3 of air) 5 d a wk (4 h/d) for 14 consecutive weeks. There were no significant differences in weight gain, haematological values, and serum chemistry data between experimental and control groups. There were no exposure-related deaths, and neither gross nor microscopic changes were attributed to test substance inhalation (CIR, 1989).
Oral:
Duration of study: 2 yr, species: rats, dose levels: 630, 1250, 2500 and 5000 ppm test substance in diet. Results: Suppression of growth occurred even at the lowest concentration (about 63 mg a.i./kg bw/d). 2500 ppm: diarrhoea and bloating of the abdomen, brown syrupy material in the intestine, distension of the caecum and foci of haemorrhagic necrosis in the gastro-intestinal tract. 5000 ppm: died with 10 weeks LO(A)EL = 2500 ppm; NO(A)EL = 630 ppm (Cutler and Drobeck 1970; BIBRA 1989).
Duration of study: 2 yr, species: rat, dose levels: 150, 310, 620, 1250, 2500 and 5000 ppm test substance in diet. Results: 1250 ppm: did not affect the growth, food consumption, blood picture or histopathology of the treated animals. 5000 ppm: 50% dead at 50 d: diarrhoea, brown viscid contents in the upper intestinal tract and acute gastritis were observed. Histopathological investigation revealed mucosal necrosis of the gastrointestinal tract. NO(A)EL = 1250 ppm (Cutler and Drobeck 1970).
Duration of study: 12 weeks, species: rat, dose levels: 50 and 100 mg/kg bw/d in water or milk. Results: Depression in weight gain was observed in rat receiving 100 mg/kg bw/d in water, but not in milk (Cutler and Drobeck 1970).
Duration of study: 52 weeks Species: dog, dose levels: 12.5, 25 and 50 mg/kg bw/d for 52 weeks. Results: Mortality occurred in dogs at 25 and 50 mg/kg bw/d in water, but not in milk. The 12.5 mg/kg bw/d dose level was well tolerated. NO(A)EL = 12.5 mg/kg bw/d in water (Cutler and Drobeck 1970)
Duration of study: 2 yr, species: rat, dose levels: 5, 12.5 and 25 mg/kg bw/d, gavage. Results: decrease in body weight at the highest dose level and increased cell growth in the gastric mucosa (Cutler and Drobeck 1970).
Duration of study: 15 weeks, species: dog, dose levels: 310, 620, 1250, 2500, 5000 and 10000 ppm in diet. Results: 2500 ppm: decreased body weight and food consumption were seen. Dog fed 5000 and 10000 ppm levels died. As in the rats, the pathological changes were restricted to the gastrointestinal tract and included haemorrhage and necrosis in the gastrointestinal mucosa. NO(A)EL = 1250 ppm (approximately 30 mg/kg bw/d) (Cutler and Drobeck 1970). - Executive summary:
Dermal:
Duration of study: 3 months, species: rat, dose level: 10 mg a.i./kg bw/d, 5 times/wk. Results: changes in the blood picture, liver and kidney damage, decreased growth, increased weight adrenals, kidney and testes.
Duration of study: 100 weeks, species: mice, dose level: 10 mg a.i./kg bw/d, 5 times/wk, open application. Results: Gross examination of major organs showed no adverse systemic effects.
Duration of study: 4 weeks / lifelong, species: rabbits, dose level: 4 weeks: 2 mg a.i./kg bw/d, 5 d/wk; lifelong: 1.7 mg a.i./kg bw/d, twice/wk; both uncovered application. Results: No adverse systemic effects.
Inhalation:
Toxicity by inhalation of vapour is not attainable at the saturated atmosphere that can be generated under ambient temperature conditions. An inhalation toxicity study of an aerosolized hair conditioner containing 0.2% of a 50.0% test solution (effective test concentration = 0.1%) was conducted in rats and Syrian Golden hamsters. The animals were exposed to the conditioner (9.9 mg/m3 of air) 5 d a wk (4 h/d) for 14 consecutive weeks. There were no significant differences in weight gain, haematological values, and serum chemistry data between experimental and control groups. There were no exposure-related deaths, and neither gross nor microscopic changes were attributed to test substance inhalation (CIR, 1989).
Oral:
Duration of study: 2 yr, species: rats, dose levels: 630, 1250, 2500 and 5000 ppm test substance in diet. Results: Suppression of growth occurred even at the lowest concentration (about 63 mg a.i./kg bw/d). 2500 ppm: diarrhoea and bloating of the abdomen, brown syrupy material in the intestine, distension of the caecum and foci of haemorrhagic necrosis in the gastro-intestinal tract. 5000 ppm: died with 10 weeks LO(A)EL = 2500 ppm; NO(A)EL = 630 ppm (Cutler and Drobeck 1970; BIBRA 1989).
Duration of study: 2 yr, species: rat, dose levels: 150, 310, 620, 1250, 2500 and 5000 ppm test substance in diet. Results: 1250 ppm: did not affect the growth, food consumption, blood picture or histopathology of the treated animals. 5000 ppm: 50% dead at 50 d: diarrhoea, brown viscid contents in the upper intestinal tract and acute gastritis were observed. Histopathological investigation revealed mucosal necrosis of the gastrointestinal tract. NO(A)EL = 1250 ppm (Cutler and Drobeck 1970).
Duration of study: 12 weeks, species: rat, dose levels: 50 and 100 mg/kg bw/d in water or milk. Results: Depression in weight gain was observed in rat receiving 100 mg/kg bw/d in water, but not in milk (Cutler and Drobeck 1970).
Duration of study: 52 weeks Species: dog, dose levels: 12.5, 25 and 50 mg/kg bw/d for 52 weeks. Results: Mortality occurred in dogs at 25 and 50 mg/kg bw/d in water, but not in milk. The 12.5 mg/kg bw/d dose level was well tolerated. NO(A)EL = 12.5 mg/kg bw/d in water (Cutler and Drobeck 1970)
Duration of study: 2 yr, species: rat, dose levels: 5, 12.5 and 25 mg/kg bw/d, gavage. Results: decrease in body weight at the highest dose level and increased cell growth in the gastric mucosa (Cutler and Drobeck 1970).
Duration of study: 15 weeks, species: dog, dose levels: 310, 620, 1250, 2500, 5000 and 10000 ppm in diet. Results: 2500 ppm: decreased body weight and food consumption were seen. Dog fed 5000 and 10000 ppm levels died. As in the rats, the pathological changes were restricted to the gastrointestinal tract and included haemorrhage and necrosis in the gastrointestinal mucosa. NO(A)EL = 1250 ppm (approximately 30 mg/kg bw/d) (Cutler and Drobeck 1970).
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