Zinc 5-nitroisophthalate

Acute Toxicity: dermal

Administrative data

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

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

skin irritation: in vivo

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

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981-05-12

Deviations:

yes

Remarks:

no detailed description of test performance, size of dermal application area are not described, exposure time too long (20 hours), scoring after 24 hours and 8 days only, no Draize scale was used

GLP compliance:

no

Remarks:

not mandatory at the time of study conduct

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system 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

Preparation of test site:

not specified

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Concentration: 2 g of a 50% aqueous solution (equivalent to 1 g of pure substance)

Duration of treatment / exposure:

1 min, 5 min, 15 min and 20 hours

Observation period:

8 days

Number of animals:

4 (in the results, only 2 animals are listed)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 1, 5 and 15 minutes appplication the treated skins were first cleaned with undiluted lutrol and then with 50% aqueous solution of lutrol. After 20 hours of exposure, the skin was not cleaned.

OBSERVATION TIME POINTS
- at 24 hours and 8 days after application

SCORING SYSTEM:
- Method of calculation: no Draize scale was used

EXAMINATIONS performed:
- local irritant effects and clinical signs

Remarks on result:

other: After 24 hours 2 animals showed a questionable overlapping redness on the back following 20 hours exposure time. No more irritant effects were observed. Full reversibility of effects after 8 days.

Irritant / corrosive response data:

After 24 hours 2 animals showed a questionable overlapping redness on the back following 20 hours exposure time.
No more irritant effects were observed. Full reversibility of effects after 8 days.
The other two animals are not listed.

Other effects:

No clinical signs were observed.

EAR:

After 24 hours 2 animals showed a questionable redness on the ear for 20 hours exposure time. Full reversibility of effects after 8 days.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on this vivo study (OECD 404), the substance is not irritating to the skin.
According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance does not require classification as skin irritant.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

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

Test material information

Constituent 1

Test material form:

liquid - solid: mixture of

Details on test material:

50% aqueous suspension of zinc 5-nitroisophthalate

Test animals

Species:

rabbit

Strain:

Vienna White

Sex:

not specified

Details on test animals or test system 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

Administration / exposure

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

Results and discussion

Preliminary study:

not applicable

Effect levels

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

Applicant's summary and conclusion

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.