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EC number: 204-707-7 | CAS number: 124-64-1
Toxicological information
Repeated dose toxicity: dermal
Currently viewing:
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Published test report from Nagoya Medical Journal Evaluated data from a reliable secondary source (US-CPSC, 1999; ACGIH, 2005).
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 000
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
- Principles of method if other than guideline:
- Rabbits and rats were dosed daily for 20 days with 15%, 20%, or 30% queous solutions of THPC.
Treated animals were continuosly placed under observation even therafter the treatment was discontinued. All animals wer sacrificed after
completion of the experiments and their hematoxylin-eosin stained skin specimens were histological examined. - GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Tetrakis(hydroxymethyl)phosphonium chloride
- EC Number:
- 204-707-7
- EC Name:
- Tetrakis(hydroxymethyl)phosphonium chloride
- Cas Number:
- 124-64-1
- Molecular formula:
- C4H12O4P.Cl
- IUPAC Name:
- tetrakis(hydroxymethyl)phosphonium chloride
Constituent 1
Test animals
- Species:
- other: rats and rabbits
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- 88 healthy male white rats of the same strain (bw: 250-300g) were used in a comparative assessment for 7 test items.
30 healthy male white rabbits of the same strain (bw: 3000g) were used in a comparative assessment for 7 test items.
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- water
- Details on exposure:
- 3 mm portion of the hair from its root was left.
rat: 15%/20%/30% aqueous solutions of THPC (rat: 0.75 ml were applied to 3x3 cm area), corresponding to 450/600/900 mg/kg bw/day (Bittner, CSPC, 1999))
rabbit: 15% and 30% aqueous solutions of THPC (rabbit: 1 ml were applied to 4x4 cm area), corresponding to 50 and 100 mg/kg bw/day (Bittner, CSPC, 1999) - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- observation period = treatment period (20 days)
- Frequency of treatment:
- once a day for 20 consecutive days
- No. of animals per sex per dose:
- rats: 4 per dose group
rabbits: 2 per dose group - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Protocol amendment: Treatment with THPC were discontinued after day 8 (rats) or after day 6 (rabbit) because of local effects (redness) beginning on day 2 and marked body weight loss. Treated animals were necropsied on day 12 (rats).
Examinations
- Observations and examinations performed and frequency:
- Rat: Skin reactions beginning on day 2, intensifying till day 6. Falling-off of hair on day 7. The application in rats was discontinued on day 8, but all animals showed marked body weight loss and eventually died on day 9 (high dose group). Surviving animals were necropsied on day 12 (rats).
Rabbit: Redness of skin
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Dermal irritation:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- Rat: Skin reactions beginning on day 2, intensifying till day 6. Falling-off of hair on day 7. The application in rats was discontinued on day 8, but all animals showed marked body weight loss and eventually died on day 9 (high dose group) and were necropsied on day 12 (rats).
Rabbit: Redness of skin on the 2nd day.
Histopathologic findings of the skin: Erythema and epidermal atrophy were observed when rats were treated with 15%, 20%, 30%aqueous THPC (450, 600, 900 mg/kg/day) for 8 days; and all rats of the highest dose group (30% THPC, 900 mg/kg) died after 9 days administration.
When rabbits were treated dermally with a 15% (50 mg/kg/day) THPC solution, severe redness was noted within 6 days; histopathological examination showed subepidermal fibrosis, without the regeneration of papillae, at the 30% concentration (100 mg/kg/day).
Effect levels
open allclose all
- Dose descriptor:
- LOAEL
- Remarks:
- rat, local
- Effect level:
- <= 15 mg/cm² per day
- Based on:
- act. ingr.
- Sex:
- male
- Basis for effect level:
- other: severe skin effects at site of contact.
- Dose descriptor:
- LOAEL
- Remarks:
- rat, systemic
- Effect level:
- <= 450 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Sex:
- male
- Basis for effect level:
- other: marked body weight loss, death of all high dose animals on day 9 (900 mg/kg bw/day)
- Dose descriptor:
- LOAEL
- Remarks:
- rabbit, local
- Effect level:
- <= 17 mg/cm² per day
- Based on:
- act. ingr.
- Sex:
- male
- Basis for effect level:
- other: severe skin effects at site of contact
- Dose descriptor:
- LOAEL
- Remarks:
- rabbit, systemic
- Effect level:
- <= 50 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Sex:
- male
- Basis for effect level:
- other: falling-off of hair, treatment discontinued after day 6
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Low dose groups (15% THPC) showed severe local effects in both rats and rabbits.
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