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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: 2e The study meets generally accepted scientific principles, but was not conducted in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
Conducted prior to adoption of OECD test guidelines.
Deviations:
yes
Remarks:
Limited detail on test substance, methods and animals/conditions.
Principles of method if other than guideline:
Method: other: Insufficient detail to fully assess comparability with OECD guideline.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: 1.8 to 2.0 kg
- Fasting period before study: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data


IN-LIFE DATES: No data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: No data
- % coverage: No data
- Type of wrap if used: 'plastic strips'


REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: No data


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): No data
- Constant volume or concentration used: No data



Duration of exposure:
24 hours
Doses:
3160, 5010, 7940 and 7940 mg/kg bw
No. of animals per sex per dose:
One male or female animal per dose.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, and macroscopic examination of all animals.
Statistics:
None

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 7 940 mg/kg bw
Remarks on result:
other: equivalent to >4605 mg active acid/kg bw
Mortality:
No deaths occurred.
Clinical signs:
Clinical symptoms included reduced appetite and activity for 1-2 days. 
Body weight:
No adverse effects reported, although the summary table shows that there was no weight change in animals five days after treatment.
Gross pathology:
No adverse findings.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute dermal toxicity study (reliability score 2), conducted prior to the adoption of OECD test guidelines and GLP, the LD50 for diethylenetriamine penta(methylene phosphonic acid) was >7940 mg/kg bw (presumed equivalent to >4605 mg active acid/kg bw) in the rabbit.
Executive summary:

In an acute dermal toxicity study (reliability score 2), conducted prior to the adoption of OECD test guidelines and GLP, diethylenetriamine penta(methylene phosphonic acid) was applied to the clipped, intact skin of four New Zealand white rabbits, under an occlusive dressing, for 24 hours. Animals were then observed for 14 days, and all animals were examined macroscopically. No animals died and the LD50 was concluded to be greater than 7940 mg/kg bw (equivalent to >4605 mg active acid/kg bw). Toxic signs included reduced appetite and activity for one to two days after treatment. There were no abnormal macroscopic findings.