Registration Dossier

Administrative data

Endpoint:
specific investigations: other studies
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: data are shown only partly, description of the results only limited

Data source

Reference
Title:
No information
Author:
Lo H-H. et al. (1990). Acute nephrotoxicity induced by isomeric dichloroanilines in Fisher 344 rats. Toxicology 63, 215-231

Materials and methods

Principles of method if other than guideline:
Method: other: single i.p. inj. to 4-8 rats and renal function was noted 24 and 48 hrs later, clin. chem. and histopathol. examin., pair-fed controls, statistics: ANOVA and/or Student's t-test
GLP compliance:
not specified
Type of method:
in vivo

Test material

Constituent 1
Chemical structure
Reference substance name:
2,3-dichloroaniline
EC Number:
210-157-9
EC Name:
2,3-dichloroaniline
Cas Number:
608-27-5
Molecular formula:
C6H5Cl2N
IUPAC Name:
2,3-dichloroaniline
Details on test material:
IUCLID4 Test substance: other TS: 2,3-dichloroaniline as hydrochloride, no data on purity

Test animals

Species:
rat

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other: 0.9 % saline
No. of animals per sex per dose:
Males 8

Results and discussion

Any other information on results incl. tables

Freetext:
mortality
1.0 mmol/kg bw-treatment group: 3/8

0.8 mmol/kg bw:
-on day 1: transient proteinuria (grade: +++ compared to control:+, data not shown)
-hematuria (grade: trace to +, data not shown)
-on day 2: significant increase in mean urine volume compaired to pair fed control: 19 ml versus 8 ml (graphic),

1.0 mmol/kg bw, day 1 (data from day 2 not shown)
-kidney weight decreased (0.35 g/100g bw versus 0.39g/100 g bw of pair fed control),
-basal and lactate-stimulated p-aminohipurate (PAH) accumulation decreased (Slice to Medium ratio [S/M ratio]: 3.8 versus 4.0 of pair fed control and 8.3 versus 10.8 of pair fed control)
-tetraethylamonium (TEA) was not reduced
-Mean blood urea nitrogen (BUN) concentration values were higher at 24 h (63.7 mg% versus 26 mg% at 0 h) than in the corresponding 48 h-treatment group (27 mg% versus 28 mg%)

Histopathological examination revealed moderate damaged proximal tubular segments of the nephron in the 0.8 and 1.0 mmol/kg bw treatment groups.

Applicant's summary and conclusion