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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
441-810-8
EC Name:
-
Cas Number:
116313-85-0
Molecular formula:
C7H5NO5
IUPAC Name:
3,4-dihydroxy-5-nitrobenzaldehyde

Test animals

Species:
rat
Strain:
Sprague-Dawley

Administration / exposure

Route of administration:
oral: feed
Vehicle:
peanut oil
Details on oral exposure:
Method of administration: forced feeding
Duration of treatment / exposure:
28 days
Frequency of treatment:
Dosing regime: 7 days/week
No. of animals per sex per dose:
Male: 10 animals at 0 mg/kg bw/day
Male: 5 animals at 15 mg/kg bw/day
Male: 5 animals at 150 mg/kg bw/day
Male: 10 animals at 500 mg/kg bw/day
Female: 10 animals at 0 mg/kg bw/day
Female: 5 animals at 15 mg/kg bw/day
Female: 5 animals at 150 mg/kg bw/day
Female: 10 animals at 500 mg/kg bw/day

Results and discussion

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
15 mg/kg bw/day (nominal)
Dose descriptor:
NOEL
Effect level:
15 mg/kg bw/day (nominal)

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Clinical observations:

Dose main groups recovery groups (mg/kg 0 15 150 500 0 500 bw/d) m f

Increased p p salivation

Noisy/ p p gasping respiration + hunched posture

Orange fur staining p p p p p p

Laboratory findings: Dose main groups recovery groups (mg/kg 0 15 150 500 0 500 bw/d) m f

related effects urinalysis volume I* I** I* specific gravity D* D** D**

Effects in organs: Dose main groups recovery groups (mg/kg 0 15 150 500 0 500 bw/d) m f

organ weight (abs. And rel): adrenals D*

Macroscopic findings: Stomach: p p thickened, raised yellowish glandular and non glandular mucosa

histopathology: acanthosis 1/5 1/5 5/5 5/5 1/5 Hyperkeratosis 1/5 5/5 5/5 1/5 1/5 Subepith. 1/5 1/5 4/5 5/5 1/5 2/5 Inflammation Ulceration 4/5 3/5 1/5

Key: - no findings/change

i* statistically significant increase compared with controls (p<0.05)

i** statistically significant increase compared with controls (p<0.01)

d* statistically significant decrease compared with controls (p<0.05)

d** statistically significant decrease compared with controls (p<0.01)

Comments:

Additional five animals per sex in the control and high dose groups were treated for 28 days and then allowed a 14-day treatment-free recovery period before sacrifice.

Applicant's summary and conclusion

Conclusions:
Not classified.