Registration Dossier

Administrative data

Description of key information

Acute oral toxicity: LD50 > 4640 mg/kg bw (equivalent or similar to OECD 401; non-GLP)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987-02-24
Deviations:
yes
Remarks:
body weight was not recorded during the observation period
GLP compliance:
no
Remarks:
not mandatory at the time of study conduct
Test type:
standard acute method
Limit test:
yes
Test material information:
Composition 1
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: WIGA, Sulzfeld
- Weight (mean): males: 235 g; females: 175 g
- Fasting period before study: ca. 16 hours before administration
- Diet (ad libitum): Altromin R 1324 (ALTROMIN GmbH, LAge/Lippe)
- Water (ad libitum)
Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- 0.5 aqueous solution of carboxymethyl cellulose

DOSAGE PREPARATION:
The product was prepared as a 46.4 % suspension in the vehicle.
Doses:
10000 mg/kg bw
No. of animals per sex per dose:
10 males / 10 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Examinations performed:
clinical signs
mortality: 1, 24 und 48 house as well as 7 and 14 days after adminsitration
- Necropsy of survivors performed: yes
Statistics:
not applicable
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
4 640 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Calculated LD50 for Sicorin RZ = 4640 mg/kg bw
Mortality:
No mortality occurred.
Clinical signs:
No symptom of poisoning was observed.
Body weight:
not specified
Gross pathology:
No findings were made during the autopsy.
Interpretation of results:
GHS criteria not met
Conclusions:
LD50 (rats, combined sexes) > 10000 mg/kg bw (calculated for Sicorin RZ = 4640 mg/kg bw)
According to the Regulation (EC) No 1272/2008 and subsequent adaptations, the substance is not acutely toxic via the oral route.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
not specified
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies
Remarks:
Deviations from the OECD guideline 402 (1981): number of animals was too low; 4 animals were apparently used during the study, but only 2 animals were mentioned in the results; size of patch area was not reported; applied dose was not clearly stated; observations period lasted 8 days only; exposure period was 20 hours at a maximum instead of 24 hours; clinical observations were not made daily; body weight measurements and gross pathology were not conducted; housing conditions were missing; hair removal was not described
Reason / purpose:
reference to same study
Related information:
Composition 1
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1981-05-12
Deviations:
yes
Remarks:
please refer to the field "Rationale for reliability incl. deficiencies" above
GLP compliance:
no
Remarks:
not mandatory at the time of study conduct
Test type:
standard acute method
Limit test:
no
Test material information:
Composition 1
Species:
rabbit
Strain:
Vienna White
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: M. Gaukler, Offenbach, Germany
- Weight (mean): 3.0 kg
- Diet (ad libitum): ssniff K-Standarddiät für Kaninchen (INTERMAST GmbH, Soest, Germany)
- Water: ad libitum
Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: the product was applied as a 50 % aqueous solution onto the skin of the back and the ear of the rabbits.
Back: a patch with the test substance solution was applied to the skin under occlusive dressing.
Ear: a cotton patch with the test substance solution was applied to the skin and fix with a gauze bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: the treated skin was washed with undiluted Lutrol 9 followed by washing with a 50% aqueous Lutrol solution. Following the 20 hour exposure, the skin was not cleaned.

TEST MATERIAL
- Concentration: 2 g of a 50% aqueous solution (equivalent to 1 g of pure substance)
Duration of exposure:
Back: 1, 5, and 15 minutes as well as 20 hours
Ear: 20 hours
Doses:
2 g of a 50% aqueous solution (equivalent to 1 g of pure substance)
No. of animals per sex per dose:
4 rabbits (NOTE: 2 animals were only stated in the result section)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 24 hours and 8 days after application observations were recorded
Observations for local irritation and clinical signs were made.
Statistics:
not applicable
Preliminary study:
not applicable
Sex:
not specified
Based on:
test mat.
Remarks on result:
other: No mortality was observed during the study. The findings collected during an 8-day observation period revealed a slight temporary irritant effect only after 20 hours of exposure. No further clinical signs were observed.
Mortality:
No mortality was observed during the study (it is assumed based on the results for clinical signs that no mortality occurred even 2/4 animals were not mentioned in the results).
Clinical signs:
NOTE: 2/4 animals were not mentioned in the results. Results were only mentioned for 2 animals)

Back:
24 hours after application: 2 animals showed a questionable overlapping redness on the back following the 20 hour exposure period.
8 days after application: no irritating effects were observed

Ear:
24 hours after application: redness was observed in two animals following the 20 hour exposure period.
8 days following application: no irritating effects were observed.

No futher clinical signs were observed.
Body weight:
no data
Gross pathology:
no data
Interpretation of results:
study cannot be used for classification
Conclusions:
No mortality was observed during the study. The findings collected during an 8-day observation period revealed a slight temporary irritant effect only after 20 hours of exposure. No further clinical signs were observed.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Justification for classification or non-classification

Acute oral toxicity

The substance is not acutely toxic via the oral route based on an acute oral toxicity test (equivalent or similar to OECD 401) and does not require classification according to Regulation (EC) No 1272/2008.

Acute dermal toxicity

The substance is not acutely toxic via the dermal route based on a poor dermal absorption rate, low systemic toxicity seen in an acute oral toxicity test and no toxicity in a supporting acute dermal toxicity study. Consequently, zinc 5 -nitroisophthalate does not require classification according to Regulation (EC) No 1272/2008.

Specific target organ toxicant (STOT) - single exposure: oral

Reversible or irreversible adverse health effects were not observed immediately or after exposure in an acute oral toxicity test (equivalent or similar to OECD 401).Thus, the classification criteria as specific target organ toxicant (STOT) – single exposure, oral are not met and the substance does not require classification according to Regulation (EC) No 1272/2008 and subsequent adaptations.