Registration Dossier

Administrative data

Description of key information

rat, oral (OECD 401): LD50 > 5000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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.
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
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
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
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw
Quality of whole database:
The available information comprises adequate, reliable (Klimisch score 2-4) and consistent studies, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

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

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, 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.

 

In an additional study, acute oral toxicity was investigated similar to OECD 401 (Anonymous, 1977). A group of 5 female rats was treated with 15000 mg/kg bw propylparaben by oral gavage. No mortality occurred and no clinical signs were observed during the observation period of 7 days. Necropsy of the animals did not reveal any abnormalities.

Therefore, the LD50 is > 15000 mg/kg bw for female rats.

 

In a further study in mice performed similar to OECD 401, an oral LD50 of > 8000 mg/kg bw was determined after an observation period of 7 days (Matthews et al., 1956).


Justification for selection of acute toxicity – oral endpoint
The selected study is the most adequate and reliable study based on overall quality assessment (refer to the endpoint discussion for further details).

Justification for classification or non-classification

The available data on the acute oral toxicity of the test substance does not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and is therefore conclusive but not sufficient for classification.