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Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only secondary source available
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
secondary source
Title:
Growth-retarding activity and chemical structure of certain derivatives of itaconic acid
Author:
Karanov EN, Vasilev GN, Hristova LN
Year:
1975
Bibliographic source:
Doklady Bolgarskoi Akademii Nauk 28(8):1085-8

Materials and methods

Limit test:
no

Test material

Constituent 1
Reference substance name:
Itaconic acid, Monomethyl ester of itaconic acid, Monoethyl ester of itaconic acid and Diethyl ester of itaconic acid
IUPAC Name:
Itaconic acid, Monomethyl ester of itaconic acid, Monoethyl ester of itaconic acid and Diethyl ester of itaconic acid
Details on test material:
- Name of test material (as cited in study report):
Itaconic acid
Monomethyl ester of itaconic acid
Monoethyl ester of itaconic acid
Diethyl ester of itaconic acid

Test animals

Species:
mouse
Strain:
other: Agness Blum albino mice
Sex:
not specified
Details on test animals or test system and environmental conditions:
no data

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
not specified
Details on exposure:
no data
Doses:
not reported
No. of animals per sex per dose:
no data
Control animals:
not specified
Details on study design:
no data
Statistics:
no data

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 600 mg/kg bw
Based on:
test mat.
Remarks on result:
other: The value is an estimation based on comparable values for Itaconic acid, Monomethyl ester of itaconic acid, Monoethyl ester of itaconic acid and Diethyl ester of itaconic acid, which were all between 500 and 600 mg/kg bw (see Table 1).
Mortality:
no data
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data

Any other information on results incl. tables

- Table 1: Acute toxicity of derivatives of itaconic acid

Substance

LD 50 (mouse) in mg/kg bw after ip injection

Itaconic acid

500

Monomethyl ester of itaconic acid

500

Monoethyl ester of itaconic acid

500

Diethyl ester of itaconic acid

600

Applicant's summary and conclusion

Conclusions:
The acute toxicity of dimethyl itaconate after ip injection in mice is approximated based on a read across from several derivatives of itaconic acid. The LD 50 (mouse) after ip injection is ca. 500 mg/kg bw.
Executive summary:

The autors of a secondary source publication shortly report the acute toxicity of different derivatives of itaconic acid (Itaconic acid, Monomethyl ester of itaconic acid, Monoethyl ester of itaconic acid and Diethyl ester of itaconic acid) after ip injection in Agness Blum albino mice.

As all these substances have a comparable acute toxicity and are structurally closely related to dimethyl itaconate (DMI), the acute toxicity of DMI in mice after ip injection can be approximated based on a read across from several derivatives of itaconic acid. The LD 50 (mouse) after ip injection is ca. 500 mg/kg bw.