Magnesium, bis[2-(hydroxy-.kappa.O)benzoato-.kappa.O]-, ar, ar'-di-C14-18-alkyl derivs.

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986-10-06 to 1987-01-10

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards, well documented and acceptable for assessment. Combined study report, hence some detail issues.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Magnesium, bis(2-hydroxybenzoato-O1,O2)-, ar,ar'-di-C14-18alkyl derivs.

EC Number:

931-371-5

Cas Number:

171171-80-5

IUPAC Name:

Magnesium, bis(2-hydroxybenzoato-O1,O2)-, ar,ar'-di-C14-18alkyl derivs.

Details on test material:

- Name of test material (as cited in study report): [CAS Number 171171-80-5]
- Physical state: Dark brown viscous liquid
- Lot/batch No.: XSA 053J
- Storage condition of test material: In the dark at ambient temperature
- Stability under test conditions: Infra-red spectra taken on 14 August 1986 and 18 December 1986 showed no differences and the substance was judged to have been stable for the duration of the study

Test animals

Species:

rat

Strain:

Fischer 344

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River UK Ltd
- Age at study initiation: 9-11 weeks
- Weight at study initiation: 208-224 g (males) and 135-155 g (females)
- Fasting period before study: overnight (18 h)
- Housing: On arrival, animals were housed in single sex groups of up to 12 in a cage with each cage measuring 56 cm x 38 cm x 18 cm. The animals were quarantined in non-barried animal rooms with access restricted to essential personnel. Prior to experimentation, the animals were rehoused (as single sex groups of four) in cages with stainless steel wire-mesh floors and tops; each cage measuring 38 cm x 25 cm x 18 cm. The cages were mounted in five rows of four on both sides of a double-sided rack (a total of 40 cages). Paper-lined trays for excreta were placed beneath each cage.
- Diet: PRG, Labsure Animal Foods, Dorset ad libitum by means of a top loading food hopper (except during the 24 hours after dosing)
- Water: Filtered but untreated water from the public supply ad libitum by means of an automatic valve-regulated drinking line
- Acclimation period: = 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 degrees Centigrade
- Photoperiod: Automatically controlled cycle of light (06:00 to 18:00) and dark (18:00 to 06:00)

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The day before dosing (day zero) approximately 60 % of the dorsal hair of all animals was closely shorn with fine electric clippers. Immediately before application of the test material, the skin was visually inspected to ensure that all micro-abrasions of the stratum corneum had healed. The calculated dose was applied to the shorn skin at room temperature by syringe, the dose being altered by varying the volume dispensed from the syringe. The test material was covered with a piece of aluminium foil lined with gauze and the foil held in place by a double overwrap of waterproof adhesive tape.

Duration of exposure:

24 h

Doses:

2000 mg/kg

No. of animals per sex per dose:

Five males and five females

Control animals:

no

Details on study design:

At least two days before dosing, the rats to be used were housed in groups of two or three animals of the same sex per cage and each animal individually earmarked. The animals were weighed on the day of dosing (day 1). The rats were individually housed for 24 hours after dosing, with food withheld but water available ad libitum. At the end of the 24 h exposure period, the tape and foil were carefully removed and the skin washed with warm dilute detergent solution and then dried. The animals were then returned to group housing. The animals were observed for signs of toxicity for 14 days after dosing. Observations were recorded up to three times a day during the first three days and daily thereafter. Initial (day 1), day 7 and day 14 body weights were recorded.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: maximum dose that could be applied

Mortality:

None of the rats died

Clinical signs:

other: Inflamation of the treated site (see Tables 1 and 2, attached)

Applicant's summary and conclusion

Conclusions:

The acute percutaneous LD50 of the undiluted test substance was greater than 2000 mg/kg, the maximum dose that could be applied.