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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
1941
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study without detailed documentation, for a read-across substance.

Data source

Reference
Reference Type:
publication
Title:
THE SINGLE DOSE TOXICITY OF SOME GLYCOLS AND DERIVATIVES
Author:
Smyth HF, Seaton J & Fischer L
Year:
1941
Bibliographic source:
Journal of Industrial Hygiene and Toxicology, 23(6): 259-268

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
- equivalent or similar to OECD Guideline 401; reliability scoring based on 2001 guideline
Deviations:
yes
Remarks:
- lack of details in experimental methods and results
GLP compliance:
no
Remarks:
- Study predates GLP requirements.
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Lactic acid
EC Number:
200-018-0
EC Name:
Lactic acid
Cas Number:
50-21-5
Molecular formula:
C3H6O3
IUPAC Name:
2-hydroxypropanoic acid
Details on test material:
- Name of test material (as cited in study report): Lactic acid.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Commercial breeders; not specified.
- Age at study initiation: Not reported.
- Weight at study initiation: 90 to 120 g.
- Fasting period before study: Not reported.
- Housing: Not reported.
- Diet (e.g. ad libitum): The animals received an adequate diet of Purina chows, supplemented by fresh vegetables. The diet was given in the afternoon.
- Water (e.g. ad libitum): Water (source not specified), ad libitum.
- Acclimation period: Not reported.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported.
- Humidity (%): Not reported.
- Air changes (per hr): Not reported.
- Photoperiod (hrs dark / hrs light): Not reported.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: Not reported
- Amount of vehicle (if gavage): Not reported
- Justification for choice of vehicle: Not reported


MAXIMUM DOSE VOLUME APPLIED: Not reported
Doses:
Maximum concentration of 5% (doses not specified).
No. of animals per sex per dose:
10 males per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: Not reported.
- Necropsy of survivors performed: No.
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: Any victims whose death was inconsistent with the indications from others receiving the same substance was autopsied, and if found to be infected, it was not included in the calculations.
Statistics:
The data were calculated by the method of probits, described by Bliss (1935, 1938). No attempt was made to use adequate animals to obtain extreme precision in the LD50 figures, for the use to which such information is put seldom justifies extreme accuracy. The precision is indicated by the range of 95% probability listed in the tables.

Results and discussion

Preliminary study:
Not applicable.
Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
3.73 other: g/kg bw
95% CL:
3.02 - 4.61
Remarks on result:
other: Slope = 4.04
Mortality:
Not reported.
Clinical signs:
other: Not reported.
Gross pathology:
Not reported.
Other findings:
Not reported.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP (EC 1272/2008)
Executive summary:

The work of this group pre-dates range finding toxicity guidelines and provided much of the basis for their development. Their results are cited by many subsequent authoritative review bodies and are often found in SIDS and SIAR documents via secondary references. Therefore, these results are deemed reliable.