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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
repeated dose toxicity: oral
Remarks:
other: non-standard (see below)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reasonably well documented study meeting generally accepted scientific principles but not conducted in compliance with GLP. Study acceptable for assessment. This result was obtained by valid read-across.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Principles of method if other than guideline:
In a non-standard study, groups of 10 rats of each sex were treated by gavage for 5 successive days with a further 10 days observation. Body weights were recorded prior to treatment and following the 5th administration. (Group numbers are not given in the 2-page report seen by this reviewer, however SIAR (2001), reviewing the same study (possibly with a fuller report). has identified group numbers.)
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
administration on 5 successive days.
Frequency of treatment:
daily
No. of animals per sex per dose:
10 (based on data from SIAR, 2001)
Control animals:
not specified

Results and discussion

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
4 000 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: overall effects clinical signs; mortality; body weight NOAEL values for males and females were identical.
Dose descriptor:
LOAEL
Effect level:
8 000 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: overall effects clinical signs; mortality; body weight LOAEL values for males and females were identical

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Table 1: Study design - Animal assignment

Test Group

Dose to each sex (mg/kg bw)

1

2000 

2

4000

3

 8000

4

 16000

Table 2: Mortality and body weight gains during 5 days of treatment and 10 days of observation

Male

Female

Dose rate (g/kg bw/day)

Mortality%

(treatment day)

Mortality%

(after 10 days observation)

Total Weight Gain 24 h after 5th administration

(g)

Mortality%

(treatment day)

Mortality%

(after 10 days observation)

Total Weight Gain 24 h after 5th administration

(g)

1

2

3

4

5

1

2

3

4

5

2

 0

0

0

0

0

0

19.4

 0

0

0

0

0

0

14.0

4

 0

0

0

0

0

0

15.9

 0

0

0

0

0

0

17.7

8

30

70

80

80

100

100

-

70

80

80

90

100

100

-

16

 70

100

100

100

100

100

-

 100

100

100

100

100

100

-

 

Applicant's summary and conclusion

Conclusions:
A fairly limited report of an unspecified study without guideline or GLP compliance, identified 5-day NOAEL and LOAEL values in male and female rats of 4 and 8 g/kg bw/day, respectively. The 5-day LD50 was given as 5.6 (+/- 0.44) g/kg bw/day. For each of these values, the results for males and females, tested separately, were identical.