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Acute Toxicity: oral

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acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant, guideline study, unpublished report available, no restrictions, fully adequate for assessment.

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guidelineopen allclose all
according to guideline
EPA OPP 81-1 (Acute Oral Toxicity)
according to guideline
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
Test type:
standard acute method
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
Details on test material:
Trade name: Sulfur technical (SWPF)
Lot number: 1089 DLD
Supplier: Sandoz Agro BP 2, 27600 Gaillon, France
Appearance: Yellow powder
Storage: Room temperature in the dark
Stability: Expiry date of 14-6-1995
A.I. content: Sulfur 100% w/w

Test animals

Details on test animals or test system and environmental conditions:
Male and female Wistar (HanIbm:WIST) rats were obtained from BRL Breeding Laboratories, CH-4414 Fullinsdorf, Switzerland, at approximately 8-9 weeks of age, all individuals being within a weight range of ±10% of the mean value for each sex on delivery. The females were nulliparous and non-pregnant.
Animals were acclimatised for approximately one week before application. Animals allocated to the study were examined by a veterinarian during the acclimatisation period before being authorised for use on the study. At application, the animals were approximately 9-10 weeks old.

Housing: maximum of 5 per cage in Macrolon size 4 plastic cages with solid bottoms and sifted granular wood provided as bedding (except
for the period overnight before and 4 hours after application, when the animals were individually caged with wire mesh floors
without access to food)
Food: KLIBA pelletted diet no. 24-353-4, (Klingentalmuhle AG. Basel, CH-4303 Kaiseraugst, Switzerland) ad libitum, offered freshly weekly
Water: Municipal supply of Muttenz/BL, ad libitum from polyethylene bottles, offered freshly each week.
Light cycle: 12 hours fluorescent light and 12 hours dark per day
Environment: Air-conditioned animal room at 23-24°C, 10-15 air changes per hour, relative humidity 54-62%

Administration / exposure

Route of administration:
oral: gavage
corn oil
Details on oral exposure:
Sulphur technical was administered as suspension in corn oil (initial concentration 200 mg/ml).
A weight/volume solution was prepared in a measuring cylinder on a tared electronic balance and stirred with a glass rod. The test solution was prepared on the day of application, maintained in suspension using a magnetic stirrer, and used as soon as possible.
2000 mg/kg bw (nominal)
2249 mg/kg bw (by calculation of material applied from that remaining before and after application)
No. of animals per sex per dose:
5 males and 5 females
Control animals:
Details on study design:
Animals were fasted overnight (18-19 hours) before application and for 4 hours after application in a wire mesh-bottomed cage. For each group, the day of dosing was designated day 0. A single dose was administered to each animal by oral gavage using a syringe and metal canula or plastic tube. 14 Days after application all surviving were sacrificed.

- mortality, signs of gross ill-health, clinical signs and body weight at defined time points;
- complete post-mortem examination.
No statistical analysis was performed.

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: minor clinical signs and no mortality
No mortality was observed.
Clinical signs:
other: Clinical signs (laboured respiration, rales (in 1 male only), nose staining, and piloerection) were seen in both male and female rats, but animals affected recovered within 5 days.
Gross pathology:
Findings at necropsy were considered to reflect the normal spectrum of spontaneous lesions present in rats of this strain and age.
Other findings:
Increases in bodyweight of treated rats after application were considered normal, indicating that any toxic effect was very slight.

Applicant's summary and conclusion

Interpretation of results:
not classified
Migrated information Criteria used for interpretation of results: EU
Following oral adminsitration of sulfur to rats at a dose of 2000 mg/kg, there were no deaths and no significant signs of toxicity were observed. The oral LD50 was > 2000 mg/kg
Executive summary:

In a GLP compliant OECD guideline 401 oral acute toxicity study, groups of 5 male and 5 female Wistar rats received a single oral dose of 2000 mg/kg bw of sulfur technical (SWPF) (powder) by gavage. The animals were observed for 14 days after administration after which survivors were sacrificed and necropsied. No animals died as a result of treatment. Clinical signs such as laboured respiration, rales (in 1 male only), nose staining, and piloerection were seen in both male and female rats, but the animals recovered within 5 days.

The oral LD50 value for sulfur technical (SWPF) (powder) is higher than 2000 mg/kg bw based on this study.