Registration Dossier

Toxicological information

Repeated dose toxicity: dermal

Currently viewing:

Administrative data

short-term repeated dose toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets the criteria for Klimisch code 1. Study is classified as Klimisch code 2 only because it is based on read across.

Data source

Reference Type:
study report

Materials and methods

Test guideline
according to guideline
OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
GLP compliance:

Test material

Constituent 1
Reference substance name:
Sulfonic acids, petroleum, calcium salts, overbased
EC Number:
EC Name:
Sulfonic acids, petroleum, calcium salts, overbased
Cas Number:
Constituent 2
Reference substance name:
petroleum derived calcium salt, overbased
petroleum derived calcium salt, overbased
Details on test material:
the test material described as a petroleum derived calcium salt, overbased, belongs to the same chemical group as the submission substance (aryl / alkyl sulfonates)

Test animals

Details on test animals or test system and environmental conditions:
Sprague Dawley CD rats, 8-9 weeks of age at initiation

Administration / exposure

Type of coverage:
unchanged (no vehicle)
Details on exposure:
test substance was applied undiluted to the clipped dorsal surface for periods of 6h per day of study. material was held in place by a gauze patch secured with tape. after each exposure period the treated area was wiped. the procedure was repeated daily for 28d.
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
6h per day for 28d
Frequency of treatment:
Doses / concentrations
Doses / Concentrations:
0, 100,300 and 1000 mg/kg bwt
nominal per unit body weight
No. of animals per sex per dose:
Control animals:
yes, sham-exposed
Positive control:


Observations and examinations performed and frequency:
clinical observations daily
dermal reposes on days 0,1,4,7,11,14,18,21,25 and prior to blood collection on d28
body weight and food consumption during treatment and recovery
Hematology and clinical chemistry at termination of treatment and recovery
Microscopic examination on all animals
Sacrifice and pathology:
full range of evaluations performed
ANOVA with Dunnets test, Kruskal-Walis, Dunns summed rank test , Jonkheere test for monotonic trend, Students t test

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Dermal irritation:
effects observed, treatment-related
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
no effects observed
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
no effects observed
Details on results:
No mortality occurred during the study. Low incidences of very slight erythema, desquamation and / or pinpoint scabbing were observed sporadically in all treated animals. All animals were free of edema during the study. Body weights and food consumption were unremakable. There were no treatment related differences in heamatology. Differences from control were noted for several heamatology parameters including a statistically significant increase in mean % of neutrophils of 300 and 1000 mg/kg females and a decrease in mean % of lymphocytes in the 1000mg/kg females compared to controls on d28. In the absence of differences from control in absolute white blood cell counts, these findings were not considered related to treatment. There was a statistically significant decrease in mean corpuscular haemoglobin concentration in the male satellite animals from d28-42. In the absence of other significant findings these small differences were not considered clinically significant. Serum chemistry values were unremakable. Gross mostmortem findings were considered incidental and unrelated to treatment. There were no alterations in organ weights that were attributed to treatment.There were no test material related microscopic findings noted in any group. Effects on the skin were seen in all groups including control but tended to increase in male treated animals and females in the 300 and 1000 groups, indicating a mild irritant effect of the test article.

Effect levels

Dose descriptor:
Effect level:
> 1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Basis for effect level:
other: no adverse effects at any concentration tested

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

No evidence of systemic toxicity via the dermal route.
Executive summary:

the test article exhibited no evidence of systemic toxicity via the dermal route under the conditions of this study. A NOAEL of >1000 mg/kg bw was established.