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Toxicological information

Acute Toxicity: dermal

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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:
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:
reference to same study
Related information:
Composition 1
Reference:
Composition 0
Qualifier:
equivalent or similar to
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
Test material information:
Composition 1
Species:
rabbit
Strain:
Vienna White
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
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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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.