Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD guideline and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Alcohols, C6-12
EC Number:
271-642-9
EC Name:
Alcohols, C6-12
Cas Number:
68603-15-6
IUPAC Name:
octan-1-ol
Details on test material:
- Name of test material (as cited in study report): Tradename Linevol 79, C6-12 alcohols Type C

- Physical state: a clear, colourless liquid

- Storage condition of test material: cool conditions (not exceeding 15C)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Froxfield Farm, Hampshire, UK
- Age at study initiation: ca 3 month
- Weight at study initiation: 2.25 -2.5 kg
- Housing: individually housed in suspended stainless steel cages mounted in mobile batteries
- Diet: standard pellet rabbit diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: yes, but not specified



ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-23
- Humidity (%): 40-70
- Air changes (per hr): min. 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Remarks:
undiluted
Controls:
other: Untreated site on same animals with semi-occlusive dressing.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
Duration of treatment / exposure:
4 hour(s)
Observation period:
Examination time points: 1, 24, 48 and 72 hours then at days 7, 10, 13  and 16.
Number of animals:
3F
Details on study design:
TEST SITE
- Area of exposure: 3 X 2 cm


REMOVAL OF TEST SUBSTANCE
- Washing (if done): removed with warm water & paper tissues
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24/48/72h
Score:
1.9
Max. score:
2.7
Reversibility:
fully reversible within: 10 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/48/72h
Score:
1.1
Max. score:
1.3
Reversibility:
fully reversible within: 10 days
Irritant / corrosive response data:
- Erythema: Individual 24+48+72 hour scores are 0.7, 2.3 and 2.7 (group  mean 1.9)
- Oedema: Individual 24+48+72 hour scores are 0.7, 1.3 and 1.3 (group  mean 1.1)

All scores for erythema and oedema were 0 at day 10. 
Other effects:
Erythema extended beyond the test site in 2 animals at 24  hours and in all animals at 48 and 72 hours and remained beyond the test  site in one animal at day 7. Fissuring was also observed in this single  animal at day 7.  Loss of elasticity was noted from 48 hours after  removal of dressings until day 10. Exfoliation was observed from day 7  persisting in one animal until day 16 while lack of hair growth was  observed in all animals from day 10 until the end of the study on day 16.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Linevol 79 is considered a skin irritant using both the EC and GHS classification schemes (category 2).

Categories Display