Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientifically acceptable

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): DL-Lacton (rein) = DL-alpha-Hydroxy-beta, beta-dimethyly-butyrolacton
- Molecular weight: 130.14
- Other: Identification number: Mag-No 4 2576 1

Test animals

Species:
rat
Strain:
other: Roche inbred strain
Sex:
not specified
Details on test animals and environmental conditions:
no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Remarks:
probably water
Details on oral exposure:
no data
Doses:
no data
No. of animals per sex per dose:
5 - 10
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 10 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: no data
Statistics:
no data

Results and discussion

Preliminary study:
no
Effect levelsopen allclose all
Sex:
not specified
Dose descriptor:
LD50
Effect level:
9 700 mg/kg bw
Based on:
not specified
Remarks on result:
other: standard deviation is 1600 mg/kg bw
Sex:
not specified
Dose descriptor:
other: LD 10
Effect level:
6 200 mg/kg bw
Based on:
not specified
Sex:
not specified
Dose descriptor:
other: LD 90
Effect level:
15 000 mg/kg bw
Based on:
not specified

Any other information on results incl. tables

- Table 1: Results after 24 h and 10 d post dosing

Lethal dose

Time after gavage

24 h

10 d

LD10, mg/kg

6200

6200

LD50, mg/kg

9700±1600

9700±1600

LD90, mg/kg

15000

15000

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute oral test, conducted comparable to OECD 401, the LD50 of RS-Pantolactone was determined to be 9700 ± 1600 mg/kg bw for the rat 10 d after application.
Executive summary:

RS-Pantolactone (named DL-Lacton in the report) was tested for its acute oral toxicity comparable to OECD 401.

Rats were observed for 10 days after apllication.

The LD50 of the test item was determined to be 9700 ± 1600 mg/kg bw for the rat 24 and 10 d after application.

By expert judgement it is concluded that L-Pantolactone will get the same results.

L-Pantolactone: LD50 (rat): 9700 ± 1600 mg/kg