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Diss Factsheets

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:
No data
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Principles of method if other than guideline:
Not applicable.
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Octylphosphonic acid
EC Number:
225-218-5
EC Name:
Octylphosphonic acid
Cas Number:
4724-48-5
Molecular formula:
C8H19O3P
IUPAC Name:
octylphosphonic acid
Test material form:
other: White solid
Details on test material:
- Name in study report: Octylphosphonic acid
- Storage condition of test material: ambient temperature (< 25°C), stored under artificial light over silica gel.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Male/female
- Strain: Sprague-Dawley CD (Crl:CD BR)
- Source: Charles River (UK) Ltd., Margate, Kent UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 207-230 g (m) 203-229 g (f)
- Fasting period before study: overnight and 2 hours after dosing
- Housing: 5/sex/cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 50-83
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12:12

IN-LIFE DATES: from 5 June 1997 to 19 June 1997

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: 10% of the total body surface area.
- % coverage: no data
-Type of wrap if used: BLENDERM wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): no data
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): no data
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were observed for deaths or overt signs of toxicity 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days. Individual bodyweights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
No data

Results and discussion

Preliminary study:
Not applicable.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
other: No signs of systemic toxicity. Signs of skin irritation noted were very slight to well-defined erythema, very slight to slight oedema, scabbing, blanching of the skin, superficial cracking of the epidermis, crust formation, desquamation and glossy skin. T
Gross pathology:
No abnormalities noted
Other findings:
No other findings.

Any other information on results incl. tables

No other information

Applicant's summary and conclusion

Interpretation of results:
other: not classified as harmful or toxic as per the CLP Regulation EC No 1272/2008
Conclusions:
The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat (males + females) was found to be greater than
2000 mg/kg bodyweight. Based on these results, no classification is required according to the regulation (EC) N°.1272/2008 and the Directive 67/548/EEC
criteria.
Executive summary:

A study was performed to assess the acute dermal toxicity of the test material in the Sprague-Dawley CD strain rat according to OECD 402 and in compliance with GLP. A group of ten animals (five males and five females) was given a single 24-hour, semi-occluded dermal application to intact skin at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of treatment and were then killed for gross pathological examination.

There were no deaths. No signs of systemic toxicity were noted during the study. Signs of skin irritation noted were very slight to well-defined erythema, very slight to slight oedema, scabbing, blanching of the skin, superficial cracking of the epidermis, crust formation, desquamation and glossy skin. The treatment site of one female appeared normal thirteen days after dosing. All other skin sites showed signs of skin irritation up to Day 14. All animals showed an expected gain in bodyweight during the study. No abnormalities were noted at necropsy.

 

The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight. Based on these results, no classification is required according to the regulation (EC) N°.1272/2008 and the Directive 67/548/EEC criteria.

 

This acute dermal study is classified as acceptable. It satisfies the guideline requirement for an acute dermal study in the rats.