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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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
Study period:
from 4 March 1981 to 3 April 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Equivalent to guideline study with acceptable restrictions. This study is read across from citric acid (CAS 77-92-9).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Groups of 5 mice of each sex were given a single gavage dose with observation for mortality for 10 days. Clinical observations were made at 2 h and 24 h after treatment; body weights were only recorded prior to dosing. The observation period was 10 days instead of 14 recommended by guideline.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Citric acid
EC Number:
201-069-1
EC Name:
Citric acid
Cas Number:
77-92-9
IUPAC Name:
citric acid

Test animals

Species:
mouse
Strain:
other: Füllinsdorf Albino (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoffmann-La Roche & Co. Ltd, Company breeding farm: Tierfarm Füllinsdorf. (no further details)
- Age at study initiation: not stated
- Weight at study initiation: 20 g
- Fasting period before study: not stated
- Housing: 5/Macrolon type III cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: not stated

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1
- Humidity (%): 50 +/- 10
- Air changes (per hr): 20-25
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: (main study) From: 1981-03-24 To:1981-04-03

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: (main study) 150-600 mg/ml

MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg bw
Doses:
0, 3, 4.2, 6, 8.5, 13 g/kg bw
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 10 days
- Frequency of observations and weighing: clinical observations at 2 h and 24 h following treatment; observation for mortality daily for 10 days; body weights recorded only prior to treatment
- Necropsy of survivors performed: no
- Other examinations performed: none
Statistics:
probit analysis

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
5 400 mg/kg bw
95% CL:
4 500 - 6 400
Remarks on result:
other: observation limited to 10 days
Mortality:
No deaths at 3 g/kg bw, death of all exposed within 24 h at 8.5 g/kg bw, and above. See table 1.
Clinical signs:
other: Clinical observations were limited to 2 h and 24 h after treatment; the descriptions given are very limited. See table 1.
Gross pathology:
Not examined.
Other findings:
None.

Any other information on results incl. tables

Table 1: Number of animals dead and with evident toxicity and time range within which mortality occurred

Dose
(g/kg bw)

Mortality (dead/total)

Time of death (within)

Overt toxicity

Combined (5 male, 5 female)*

2 h

24 h

Control

0/10

-

none

none

3

0/10

-

none

none

4.2

2/10

24 h

none

none

6

7/10

24 h

slight relaxation

none

8.5

10/10

24 h

death

-

12

10/10

24 h

death

-

* Separate data for each sex not given

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A study conducted according to a protocol that was similar to OECD 401, but limited in some respects and without GLP status, identified an acute oral LD50 value of 5.4 g/kg bw for male and female mice. The result is read across from citric acid (CAS 77-92-9).