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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:
weight of evidence
Study period:
no data
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: The study is not detailed enough, but it can be considered as acceptable for a weight of evidence approach for the LD50 value

Data source

Reference
Reference Type:
publication
Title:
Short-term toxicity tests on the mono and di methyl ethers of hydroquinone
Author:
Hodge HC, Sterner JH, Maynard EA and Thomas J
Year:
1949
Bibliographic source:
The Journal of Industrial Hygiene and Toxicolology, 31(2), 79-92

Materials and methods

Test guideline
Guideline:
other: no data
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Monomethyl ether hydroquinone (PMP). No other information available.

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS:

- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 129 to 160 mg
- Fasting period before study: no data
- Housing: no data
- Food consumption: no data
- Water consumption: no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS: no data

In-life dates: no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
VEHICLE : no data
Doses:
150, 200, 250, 300 and 350 mg/rat
or : 1162, 1550, 1786, 2143 and 2187 mg/kg bw
No. of animals per sex per dose:
26 total
Control animals:
no
Details on study design:
no data
Statistics:
no data

Results and discussion

Preliminary study:
no data
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 1 630 mg/kg bw
Mortality:
yes, see table
Clinical signs:
no data
Body weight:
yes, see table
Gross pathology:
no data
Other findings:
no data

Any other information on results incl. tables

Dose        No.      Mean body      Mortality        Equiv. dose
(mg)        rats        weight (g)        (%)                (mg/kg bw)
---------------------------------------------------------------------
150         2         -                 0                 1262
200        10        129                40                1550
250        7        140                86                1786
300        6        140                83                2143
350        1        160                100                2187

The LD50 is of the order of 1630 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
PMP is harmful based on the LD50 in rat.
Executive summary:

In an acute oral toxicity study, groups of 1-10 rats were given a single oral dose of PMP at doses of 1162, 1550, 1786, 2143 and 2187 mg/kg bw.

Oral LD50 = ca 1630 mg/kg bw.

PMP is harmful if swallowed, based on the LD50 in rat, according to the Directive 67/548/EEC criteria (Xn R22), and to the EU CLP Regulation (EC) n°1272/2008 (acute toxicity category 4). This is also the official classification.

This acute oral study is classified as not reliable ; it does not satisfy the guideline requirement for an acute oral study in the rat, but it can be considered as acceptable.