Alkanes, C10-13, chloro

Repeated dose toxicity: dermal

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

Reference

Reference 1

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 2

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

Test material information

Constituent 1

Reference substance name:

Alkanes, C10-13, chloro

EC Number:

287-476-5

EC Name:

Alkanes, C10-13, chloro

Cas Number:

85535-84-8

IUPAC Name:

Alkanes, C10-C13, Chloro

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 or test system 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.