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Diss Factsheets

Administrative data

Description of key information

In an acute oral toxicity study in rats according to OECD method no. 401, the LD50 was determined to be 40770 mg/kg bw for males and females.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 1983
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: study performed under GLP and in accordance with the corresponding OECD-/EU-testing guidelines
Reason / purpose for cross-reference:
reference to same study
according to guideline
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
Test type:
standard acute method
Limit test:
Details on test animals or test system and environmental conditions:
- Source: Charles River (UK) Ltd., Manston Road, Margate, Kent
- Age at study initiation: between 6 and 10 weeks
- Weight at study initiation: males 129 to 151 g, females 125 to 148 g
- Housing: gang-housing in groups of 5 by sex
- Diet (e.g. ad libitum): SQC Rat and Mouse Maintenance Diet No.1, Expanded, Special Diets Services Ltd., Stepfield, Witham, Essex
- Water (e.g. ad libitum): Tap water, free of contaminants
- Acclimation period: 5 days

- Temperature (°C): 19-21°C, single air-conditioned room
- Humidity (%): 52-70%
- Photoperiod: Fluorescent lighting, automatically controlled to give a cycle of 12 hours light (06.00 to 18.00 hr) and 12 hours darkness
Route of administration:
oral: gavage
corn oil
Details on oral exposure:
see table under subsection "any other information on materials and methods incl. tables"
1770, 2500, 3530 and 5000 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: at 15 minutes, 1, 2 and 4 hours after treatment and subsequently once daily for 14 days
- Frequency of weighing: on the day before treatment (day -1), on the day of treatment, 7 and 14 days after treatment and at death
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: yes
The acute oral median lethal dose (LDso) for combined male and female groups were calculated using a probit analysis (Finney, D.J. (1964), Statistical Method for Biological Assay, 2nd Edition, London, Charles Griffin). Separate LDso values were calculated for male and female animals. The mortalities did not allow the calculation of 95% fiducial limits for male animals.
Preliminary study:
Four groups, each of 2 fasted rats (1 male, 1 female), were treated with dose levels of 50, 250, 1250 and 5000 mg/kg.
Dose descriptor:
Effect level:
4 077 mg/kg bw
Based on:
test mat.
95% CL:
3 331 - 6 052
Dose descriptor:
Effect level:
5 107 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no CL determined
Dose descriptor:
Effect level:
3 710 mg/kg bw
Based on:
test mat.
95% CL:
2 816 - 5 272
A total of 12 (5 male, 7 female) of the 40 animals died during the study period. All deaths were noted 24 or 48 hours after treatment.
Clinical signs:
other: 1770 mg/kg: All animals treated with 1770 mg/kg appeared normal 2 hours after dosing. The antmals appeared prostrate and/or lethargic 4 hours after dosing but recovered and all animals appeared normal on day one and throughout the study period. 2500 mg/k
Gross pathology:
Major pathological findings in animals dying during the study were associated with the stomach and gastrointestinal tract. These organs appeared distended or filled with gas.The lungs occasionally showed red patches on all lobes.
Interpretation of results:
not classified
Migrated information Criteria used for interpretation of results: EU
The acute oral toxicity LD50 on Wistar rats was determined to be 4077 mg/kg combined for both sexes, 5107 mg/kg for male and 3710 mg/kg for female rats.
Executive summary:

The study was performed 1983, in accordance with OECD 401 and under GLP. Following a screening study, 4 groups, each of 10 fasted rats (5 male, 5 female) were treated with a single oral dose of P5175 at dose levels of 1770, 2500, 3530 and 5000 mg/kg. The vehicle used was corn oil.

1. Clinical observations:

Clinical signs were observed throughout all dose groups and included prostration, lethargy, tremor, ataxia and piloerection. Surviving animals appeared normal within 1-2 days after treatment.

2. Mortality:

5 males and 7 females died during the study period. All deaths occured 24 or 48 hours after treatment.

Based on the test results, the test item has no classification/labelling requirements.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
4 077 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of acute toxicity – oral endpoint
GLP-study, Klimisch 1

Justification for classification or non-classification

Based on the data available the substance is not classified or labeled according to Directive 67/548/EEC (DSD) or Regulation 1272/2008/EC (CLP).