Registration Dossier

Administrative data

Endpoint:
sub-chronic toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Published study and cited in expert review; considered acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
The toxicological effects of chlorinated paraffins in mammals
Author:
Birtley RDN, Conning DM, Daniel JW, Ferguson DM, Longstaff E and Swan AAB
Year:
1980
Bibliographic source:
Toxicol. Appl. Pharmacol. 54: 514-525
Reference Type:
secondary source
Title:
Unnamed
Year:
2000

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Repeated administration to rat skin under occlusive conditions of various C10-13 chlorinated paraffins (41-70% chlorination)
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): C10-13 chlorinated paraffins (41-70% chlorination)
- Substance type: technical product
- Physical state: liquid
- Analytical purity: no data
- Composition of test material, percentage of components: (i) C10-13: 41-50% chlorination, (ii) C10-13: 51-60% chlorination, (iii) C10-13: 61-70% chlorination
- Impurites : posssible presence of stabilisers

Test animals

Species:
rat
Strain:
not specified
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: ICI Ltd, Alderley Park, Cheshire UK
- Age at study initiation: no data
- Weight at study initiation: 125-250 g
- Housing: singly
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: neat liquid or as a concentrated solution in a non-irritant vehicle
Details on exposure:
TEST SITE
- shorn back

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with dilute detergent solution
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): no data
- Constant volume or concentration used: yes

VEHICLE
- "non irritant"

Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
no data
Duration of treatment / exposure:
up to six 24 h periods
Frequency of treatment:
alternate 24 h periods
Doses / concentrations
Remarks:
Doses / Concentrations:
up to 0.1 ml
Basis:
no data
No. of animals per sex per dose:
3 females
Control animals:
not specified
Details on study design:
The test material was applied under an occlusive dressing which was kept in contact with the test material for 24 h. After removal, the skin was washed to remove residual test material and left for 24 h.
8 separate studies were carried out with compound (i), 6 with compound (ii) and 11 with compound (iii)
Positive control:
none

Examinations

Observations and examinations performed and frequency:
skin reaction assessed 24 h after removal of dressing or after washing
Sacrifice and pathology:
In some experiments an autopsy was performed (no further details given in citing source)
Other examinations:
none
Statistics:
none

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:
not specified
Food consumption and compound intake (if feeding study):
not examined
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
not examined
Clinical biochemistry findings:
not examined
Urinalysis findings:
not examined
Behaviour (functional findings):
not examined
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
not examined
Histopathological findings: neoplastic:
not examined
Details on results:
No evidence for systemic toxicity
Mild skin irritancy (erythema/desquamation) seen with some grades and occassional moderate response seen with 70% chlorinated material.

Effect levels

Dose descriptor:
NOAEL
Sex:
female
Remarks on result:
not determinable
Remarks:
no NOAEL identified

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

In some experiments an autopsy was performed, and no evidence for systemic toxicity reported

Applicant's summary and conclusion

Conclusions:
Repeated dermal application to rats of C10-13 chlorinated paraffins (with extent of chlorination varying from 41-70%) under occlusive patches at dose levels up to 0.1 ml/animal on up to six occassions produced no evidence for systemic toxicity.
Executive summary:

The dermal irritancy to 'shorn' rat skin of various samples of C10-13 chlorinated paraffins (with extent of chlorination varying from 41-70%) was investigated. Groups of 3 female rats were given up to six repeated applications of various samples of the chlorinated paraffin, either undiluted (0.1 mL) or as a concentrated solution in a non-irritant solvent (0.1 mL). The material was applied on alternate days under an occlusive dressing for 24 h periods, after which time the test material was removed by washing. In some individual experiments, an autopsy was performed to investigate signs of systemic toxicity. No signs of systemic toxicity were reported.