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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions. Necropsy was not performed in all surviving animals. Not performed according to GLP. No analytical purity was given in the study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Solbrol P
- Physical state: solid
- Analytical purity: no data

Test animals

Species:
rat
Strain:
other: Wistar (BOR:WISW)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 9 - 14 weeks
- Weight at study initiation: 182 g (males), 175 g (females)
- Fasting period before study: Animals were fasted from 16 h before application until 4 h after application. During this period tap water was available.
- Housing: Groups of five animals were housed in Makrolon cages type III with dustfree wood pellets as bedding material.
- Diet: Altromin R 1324, Altromin GmbH, Germany, ad libitum
- Water: tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1.5
- Humidity (%): 60 ± 5
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 23 Nov 1981
To: 7 Dec 1981

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Lutrol
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Animals were periodically observed for clinical signs on the treatment day and twice daily thereafter until the end of the observation period. Body weights were recorded right before application and weekly thereafter.
- Necropsy of survivors performed: yes, on a random basis
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred until the end of observation period.
Clinical signs:
No clinical signs were observed until the end of the study period.
Gross pathology:
Necropsy on a random basis revealed no substance-related findings.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 is >5000 mg/kg bw for male and female rats
Executive summary:

An acute oral toxicity study on propylparaben was performed similar to OECD 401 (Loeser, 1982). A single propylparaben dose of 5000 mg/kg bw was applied by gavage to groups of 5 male and 5 female rats. During the observation period of 14 days after application, no mortality occurred and no clinical signs were noticed. Necropsy of animals chosen on a random basis revealed no test substance related findings.Therefore, the LD50 is >5000 mg/kg bw for male and female rats.