Registration Dossier

Administrative data

Description of key information

in vivo skin irritation, test 1984, NZW rabbit on the substance 1: not skin irritant

in vitro skin irritation on FLL sample 3, sample 4 and sample 6, OECD 431: not skin irritant

in vivo eye irritation, test 1984, on the substance 1: H319 cat. 2

in vitro eye irritation on FLL sample 3, 4 and 6: not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Old study, no guideline followed.
Qualifier:
equivalent or similar to guideline
Guideline:
other: 67/548 CEE
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Housing:iron stainless steel cage model 1472 "tecniplast"
- Diet : pellet, ad libitum
- Water : municipal filtered water, ad libitum
- Acclimation period:7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):20 ± 1°C
- Humidity (%): 55 ± 15%
- Air changes (per hr):8 per hour
- Photoperiod (hrs dark / hrs light):

IN-LIFE DATES: From: To:
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g
Duration of treatment / exposure:
one application/ 4 hours
Observation period:
24, 48, 72 hours , 5, and 7 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: ~ 10 cm^2
- % coverage:
- Type of wrap if used:multiple foil surgical gauze (2.5 X 2.5 cm). The gauze is fixed by ipoallergenic adhesive bandage (Blenderm BM). The entire animal's trunk is protected by elastic bandage (Acrylastic Beyersdorf)

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

SCORING SYSTEM: according to OECD guideline 404
Erithema, Edema
Irritation parameter:
erythema score
Basis:
mean
Time point:
7 d
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
7 d
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal:
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Remarks:
at the time of testing no readings at 24, 48 and 72h were required by the guidelines
Irritation parameter:
edema score
Basis:
animal:
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Remarks:
at the time of testing no readings at 24, 48 and 72h were required by the guidelines

erithema check 1 2 3 4 5 6 mean
24h 1 2 2 1 2 2 1.66
48h 1 2 2 1 2 2 1.66
72h 1 1 2 1 1 2 1.33
5d 0 1 1 1 1 1 0.83
7d 0 0 0 0 0 0 0

erithema check 1 2 3 4 5 6 mean
24h 1 1 0 1 1 0 0.66
48h 1 1 0 1 1 0 0.66
72h 1 0 0 0 1 0 0.33
5d 0 0 0 0 0 0 0
7d 0 0 0 0 0 0 0
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on results the product Castrol oil don't presente any signs of irritation
Executive summary:

Castrol oil is tested by Decree 29/7/1983 67/548/CEE .Test item is applied on skin of six Newzeland albino rabbit. Based on results the product Castrol oil don't present any signs of irritation.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Good study, no GLP compliance
Qualifier:
according to guideline
Guideline:
other: 67/548/CEE
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: breeding center Padre Antonio
- Weight at study initiation:2 - 3 kg
- Housing: stainless steel cage 1472 Tecniplast with autowashing (10 sec. every hour)
- Diet: full pellet, ad libitum.
- Water: municipal water filtered with Seitz filter, ad libitum.
- Acclimation period: 7 days
- Healt check: 24 hours before treatment.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±1
- Humidity (%): 55±15
- Air changes (per hr):8


Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 ml/animale


Duration of treatment / exposure:
one injection
Observation period (in vivo):
1, 24, 48, 72
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM: according to DAIZE test

TOOL USED TO ASSESS SCORE: fluorescein, and UV lamp (365 nm)
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 h
Score:
ca. 0.66
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 7 days
Score:
ca. 0.66
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 h
Score:
ca. 0.33
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 7 days
Score:
ca. 0.33
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 h
Score:
ca. 2
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: conjunctive congestion score
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 7 days
Score:
ca. 1
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: conjunctive congestion score
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72
Score:
ca. 1.5
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: conjunctiva chemosis
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 7 days
Score:
ca. 0.66
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: conjunctiva chemosis
Irritation parameter:
cornea opacity score
Basis:
animal:
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Remarks:
at the time of testing no readings at 24, 48 and 72h were required by the guidelines
Irritation parameter:
iris score
Basis:
animal:
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Remarks:
at the time of testing no readings at 24, 48 and 72h were required by the guidelines
Irritation parameter:
chemosis score
Basis:
animal:
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Remarks:
at the time of testing no readings at 24, 48 and 72h were required by the guidelines
Irritation parameter:
conjunctivae score
Basis:
animal:
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Remarks:
at the time of testing no readings at 24, 48 and 72h were required by the guidelines

tissue observation period rabbit Mean
1 2 3 4 5 6
Cornea 1h 0 0 0 0 0 0 0.00
24h 1 1 1 0 1 0 0.66
48h 1 1 1 0 1 0 0.66
72h 1 1 1 0 1 0 0.66
7days 1 1 1 0 1 0 0.66
Iris 1h 0 0 0 0 0 0 0.00
24h 1 0 0 0 1 0 0.33
48h 1 0 0 0 1 0 0.33
72h 1 0 0 0 1 0 0.33
7days 1 0 0 0 1 0 0.33
Conjunctiva 1h 2 2 2 2 2 2 2.00
24h 3 3 3 2 2 2 2.50
48h 3 2 2 2 2 2 2.16
72h 2 2 2 2 2 2 2.00
7days 1 1 1 1 1 1 1.00
chemosis 1h 2 2 2 2 2 2 2.00
24h 3 2 2 3 3 3 2.83
48h 3 2 2 2 2 3 2.33
72h 2 2 1 1 1 2 1.50
7days 1 0 1 1 0 1 0.66
Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on results castrol oil is considered irritant for rabbit eyes.
Executive summary:

Castrol oil is tested on albino rabbit's eyes by DRAIZE test (67/548/ECC method). Based on results after 7 days of observation , castrol oil is considered irritant for rabbit eyes.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), a substance is classified as Eye irritant Cat 2 if at least in 2 of 3 tested animals, a positive response of:

1)     corneal opacity ≥ 1 and/or

2)     2) iritis ≥ 1, and/or

3)      conjunctival redness ≥ 2 and/or

4)      conjunctival oedema (chemosis) ≥ 2

calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days. Based on the results of the means calculated over 24/48/72h reported in the key study the substance is classified as H319, Category 2.

According to the CLP Regulation (EC 1272/2008), a substance is considered as skin irritant cat2 if:

 1) Mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or

 2)Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or

 3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.

Based on the results reported in the in vivo key study, the substance is not classified as skin irritant.