Benzenesulfonic acid, C10-16-alkyl derivs., magnesium salts

Repeated dose toxicity: dermal

Administrative data

Endpoint:

short-term repeated dose toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: study meets the criteria for Klimisch code 1.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)

Deviations:

no

GLP compliance:

yes

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sulfonic acids, petroleum, calcium salts, overbased

EC Number:

272-213-9

EC Name:

Sulfonic acids, petroleum, calcium salts, overbased

Cas Number:

68783-96-0

IUPAC Name:

68783-96-0

Constituent 2

Reference substance name:

petroleum derived calcium salt, overbased

IUPAC Name:

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). The alkyl chain lengths are, however, unspecified.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

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:

semiocclusive

Vehicle:

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:

daily

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 100,300 and 1000 mg/kg bwt
Basis:
nominal per unit body weight

No. of animals per sex per dose:

5

Control animals:

yes, sham-exposed

Positive control:

none

Examinations

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

Statistics:

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

Mortality:

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 mg.kg groups, indicating a mild irritant effect of the test article

Effect levels

Dose descriptor:

NOAEL

Effect level:

> 1 000 mg/kg bw/day (nominal)

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

No evidence of systemic toxicity via the dermal route.

Executive summary:

The test substance exhibited no evidence of systemic toxicity via the dermal route under the conditions of this study when exposed to 5 Sprague Dawley CD rats/sex/dose over a period of 28 days. A NOAEL of >1000 mg/kg bwt was established.