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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:
key study
Study period:
29/06/1981 - 12/11/1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study according to methodology comparable to OECD guideline 402. Several minor deviations from guideline. Performed under QA.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: EPA 43:163, 37336-37402 (1978)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
see overall remarks
Principles of method if other than guideline:
Not relevant
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Phosflex 72B
- Physical state: liquid

Test animals

Species:
rabbit
Strain:
other: Stauffland albino
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Phillips Rabbitry, Soquel, California
- Weight at study initiation: 1234 - 1703 g



IN-LIFE DATES: From: not mentioned To: not mentioned

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
not specified
Details on dermal exposure:
TEST SITE
- Area of exposure: abdominal skin
- Type of wrap if used: protective binder


REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bodyweight
- Constant volume or concentration used: yes
Duration of exposure:
24 hours.
Doses:
2000 mg/kg bodyweight.
No. of animals per sex per dose:
5 males and 5 females
Control animals:
yes, concurrent no treatment
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once or twice daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, local effects, necropsy
Statistics:
No data

Results and discussion

Preliminary study:
Not relevant
Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortalities were recorded in either the control or treated group during the 14-day exposure period.
Clinical signs:
The only adverse clinical sign was mild depression. The rabbits appeared normal by day 1. Local dermal effects included mild erythema and edema (1 rabbit).
Body weight:
No data
Gross pathology:
Ten rabbits were necropsied following termination on day 14 and appeared normal .
Other findings:
No data

Any other information on results incl. tables

Control animals

Four rabbits (2 male, 2 female) served as controls. They appeared normal throughout the 14 day test. There were no apparent local dermal effects following a 24 hour sham-treatment. Four rabbits were necropsied following termination on day 14 and appeared normal.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal toxicity (LD50) of Phosflex 72B towards rabbits is > 2000 mg/kg bodyweight.
Executive summary:

The acute dermal toxicity of Phosflex 72B towards male and female rabbits was investigated according to methodology comparable to OECD guideline 402. Five male and five female rabbits were exposed to the test substance for 24 hours and observed for 14 days. The LD50 (for both males and females) was found to be > 2000 mg/kg bodyweight under the conditions of this study.

Based on the results and according to the criteria outlined in regulation 1272/2008/EC (CLP/EU-GHS) Phosflex 72B does not need to be classified and has no obligatory labelling requirement for dermal toxicity.