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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
7-21 April 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was conducted to GLP, but according to an older study guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OTS 798.1100 (Acute Dermal Toxicity)
Principles of method if other than guideline:
40 CFR Part 798
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Xylene sulfonic acid, calcium salt
IUPAC Name:
Xylene sulfonic acid, calcium salt
Constituent 2
Reference substance name:
28088-63-3
Cas Number:
28088-63-3
IUPAC Name:
28088-63-3

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The exposure sites were prepared by clipping the back of each rabbit. The skin of each rabbit remained intact.
Body surface area = 9cm2.
Test site covered by 1 inch2 gauze and covered by elastic adhesive tape
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 male and 5 female
Control animals:
no
Details on study design:
Observations: 1,2 and 4 hours on Day 1 then twice daily for the following 13 days

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
Erythema in 6 animals from Day 3, reversible within the observation period in 2 animals. Disquamation in 1 animal on Day 9.
Body weight:
No abnormal changes
Gross pathology:
No abnormalities observed in 6 animals. Focal or multi-focal red discolouration in 4 animals plus disquamation in 1 of these 4 animals.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal LD50 is >2000 mg/kg.
Executive summary:

The acute dermal toxicity has been assessed by exposure of the substance to 5 male and 5 female New Zealand White rabbits at a dose volume of 2000 mg/kg according to the EPA OTS 798.1100 test method in compliance with GLP. No mortality occurred following single exposure. The dermal LD50 is >2000 mg/kg.