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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 12 January 1989 to 27 January 1989.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study, performed according to standard method.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EPA OPP 81-2 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Kanpogyo N° 39. Environmental Agency, Yakuhatsu N°. 229 MOHW, Kikyoku N°. 85 MITI.
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrakis(hydroxymethyl)phosphonium sulphate(2:1)
EC Number:
259-709-0
EC Name:
Tetrakis(hydroxymethyl)phosphonium sulphate(2:1)
Cas Number:
55566-30-8
Molecular formula:
C4H12O4P.1/2O4S
IUPAC Name:
tetrakis(hydroxymethyl)phosphonium sulphate(2:1)
Test material form:
other: liquid stored in the dark.

Test animals

Species:
rat
Strain:
other: CD rats [Crl : CD (SD) BR VAF plus]
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: charles River Laboratories, France
- Age at study initiation: 7 to 10 weeks old
- Weight at study initiation: range of 200  to 242 g
- housing: individually in metal cage
- Diet: satndard rodent diet, ad libitum
- Water: domestic quality potable, ad libitum
- Acclimation period: 22 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22-23°C
- Humidity: 47%
- Air changes: 15 per hour
- Photoperio:d 12 hr dark / 12 hr artificial light

IN-LIFE DATES: From 13 to 27 January 1989

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorso lumbar region, 50x50 mm
- % coverage: +/- 10% of the total body surface
- Type of wrap if used: gauze firmly maintained with an impermeable dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Warm (30°C-40°C) water and dried with absorbent paper
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied: 1.46 mL/kg (according to the specific density of the test substance: 1.37), but indicated as 14.6 mL/kg by typing error in the report.
Duration of exposure:
24h
Doses:
2000 mg/kg bw as active substance
1500 mg/kg bw as main ingredient
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: soon after dosing and on frequent intervals the first day (during 5 hours) and once a day hereafter, on day 1,8 and 15 for body weight
- Necropsy of survivors performed: yes, macroscopic examination
- Other examinations performed: clinical signs
Statistics:
No data.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 1 500 mg/kg bw
Based on:
act. ingr.
Remarks:
considering THPS concentration of 75%
Mortality:
After 14 days of observation, no death occurred, whatever the sex.
Clinical signs:
There were no signs of systemic reaction to treatment.
Body weight:
All rats presented anticipated body weight gains  throughout the study.
Gross pathology:
Terminal autopsy findings were normal.
Other findings:
Dermal responses: Slight or well defined erythema was observed in two  females, and they recovered on day 6 or 7 after dosing.

Any other information on results incl. tables

None.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions of this study, the combined acute median lethal dose (LD50) of the active substance (THPS 75% in water) in rat was > 2000 mg/kg bw, therefore no classification applies for this endpoint.
Executive summary:

The acute dermal toxicity test (limit test) of THPS 75% in water was assessed in a study according to the US EPA Pesticide Assessment Guidelines, Subdivision F, § 81-2 in compliance with the EPA OPPTS 870.1200 and OECD 402 guidelines and in accordance with GLP.

In this study, ten rats (5 males and 5 females) were dermally exposed to 2000 mg/kg bw of the test substance for 24 hours (equivalent to 1500 mg/kg bw as main ingredient THPS 100%). Toxicological effects (mortality, clinical signs, dermal responses, body weight) were observed during 14 days after dosing.

No death was observed at the only tested dose, that is 2000 mg/kg bw expressed as active substance, and 1500 mg/kg bw as main ingredient.

Except slight or well-defined temporary erythema observed in two females, no abnormal clinical or anatomical sign was noticed.

Under the test conditions of this study, the combined acute median lethal dose (LD50) of the active substance (THPS 75% in water) in rat was > 2000 mg/kg bw and combined rat LD50 > 1500 mg/kg bw, for the main ingredient (THPS).

This acute dermal study is classified as acceptable. It satisfies the guideline requirement for an acute dermal study in the rats.