Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986-10-06 to 1987-01-10
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 Type:
study report
Report date:

Materials and methods

Test guideline
equivalent or similar to guideline
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
Limit test:

Test material

Constituent 1
Reference substance name:
Magnesium, bis(2-hydroxybenzoato-O1,O2)-, ar,ar'-di-C14-18alkyl derivs.
EC Number:
Cas Number:
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

Fischer 344
Details on test animals or test system and environmental conditions:
- 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

- 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:
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
2000 mg/kg
No. of animals per sex per dose:
Five males and five females
Control animals:
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
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: maximum dose that could be applied
None of the rats died
Clinical signs:
other: Inflamation of the treated site (see Tables 1 and 2, attached)

Applicant's summary and conclusion

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