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Administrative data

Description of key information

Skin Irritation

Not Irritating to the skin

 

Ocular Irritation

Not irritating to eyes

 

Respiratory Irritation

No studies were located to indicate that Isoeicosane is a respiratory irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
No guideline and GLP were followed. No test substance analytical certificate available. Study conducted according to acceptable scientific conditions. Number of tested animals, applied dose, used patch, observation time and observed parameters are acceptable. Exposure time longer than requested by current OECD guideline 404.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
other: § 1500.41 Federal Register Vol. 38, No. 187, of the 27 September 1973, page 27019
Principles of method if other than guideline:
Guideline study
GLP compliance:
not specified
Remarks:
study conducted before GLP principles
Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: between 2.3 and 2.8 kg
- Housing: no data
- Diet (e.g. ad libitum): artificial prepared KF-G 774 ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 60 ± 5%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 150 Lux, 12 h light/12 h dark

IN-LIFE DATES: July 1980
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted
Duration of treatment / exposure:
24 h
Observation period:
48h after patch was removed (= 72 h after substance application)
Number of animals:
3 males + 3 females
Details on study design:
TEST SITE
- Area of exposure: 2.5 × 2.5 cm
- % coverage: no data
- Type of wrap if used: wipe of 2.5×2.5 + plastic film of the same size + rubber dressing


REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure: at 24 h removal of the patch


SCORING SYSTEM: according to OECD 404 descriptions
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 72h (no 48h scoring)
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 72h ( no 48h scoring)
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Mean 24, 48, & 72 hours scores not specified
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Mean 24, 48, & 72 hours scores not specified
Irritant / corrosive response data:
See below Table 7.3.1/1
Other effects:
No systemic effect was observed following exposure to BP Solvent IH/Isohexadecan. Behavior, general state, fur, food consumption and body weight development were normal.

Table 7.3.1/1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 4

24 h

0/1/1

0/0/0

72 h

0/0/0

0/0/0

Average 24h, 72h

0-0-0

0-0-0

Reversibility*

c

-

Average time (unit) for reversion

72h

-

* Reversibility: c. = completely reversible; = not completely reversible; n. = not reversible

Interpretation of results:
other: Not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, BP solvent IH/Isohexadecane is not classified as skin irritant according to the criteria of annex VI of the Directive 67/548/EEC and CLP Regulation 1272/2008.
Executive summary:

The skin irritating properties of the substance BP solvent IH/isohexadecane was assessed in White Vienna rabbits (3 animals of both sexes). The test substance was applied on a wipe put in contact with the shaved skin under semi-occlusive dressing for 24 hours. At the end of exposure, skin reactions were recorded both at 24 hours (patch removal) and 48 hours after the end of exposure (i.e. 72 -hour time observation) according to the Draize scale. Complete observation time was 14 days.

Moreover, the behavior, general state and food consumption were also observed. Body weight was measured every day. There was a very slight erythema (score 1) in two rabbits at patch removal (observation time = 24h). At the 72-hour observation, no erythema was observed in all 6 animals. No oedema was noted in any animal at any observation time.

No systemic effect was observed following exposure to BP Solvent IH/Isohexadecan. Behavior, general state, fur, food consumption and body weight development were normal.

Under these test conditions, the substance BP solvent IH/Isohexadecan is not classified as a skin irritant according to annex VI of the Directive 67/548/EEC and CLP Regulation 1272/2008.

Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
No guideline followed, not in compliance with GLP. No data on test substance properties (as volatility). Study conducted according to acceptable scientific conditions. Number of tested animals, applied dose, observation time and observed parameters are acceptable.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Guideline principles
GLP compliance:
not specified
Remarks:
study conducted before GLP principles
Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: own Livestock
- Age at study initiation: no data
- Weight at study initiation: between 2.5 and 2.8
- Housing: alone in V2A Steelcage. (floor surface= 0.4 m2)
- Diet (e.g. ad libitum): artificial prepared KF-G 774 ad libitum
- Water (e.g. ad libitum): tap water, ad libitum.
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 60 ± 5%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12 (150 Lux)


IN-LIFE DATES: July 1980
Vehicle:
unchanged (no vehicle)
Controls:
other: the right eye of the treated animals was used as control and received 0.1 mL NaCl physiological solution
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL BP solvent IH/Isohexadecan
- Concentration (if solution):

VEHICLE
no vehicle
Duration of treatment / exposure:
Lids were kept closed for 1 second and then the animals were set free.
Observation period (in vivo):
15 min, 1, 24, 48, 72 hours and 7 days after application
Number of animals or in vitro replicates:
6 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM: grading according to OECD 405 recommendation, scoring according to Draize

TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
- Mean individual score
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal: #2 and #3 - Mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicale
Irritation parameter:
chemosis score
Basis:
other: mean individual score for all animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
other: Mean individual score for all animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
other: Mean individual score for all animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
Irritant effects on conjunctiva (redness) were minimal at 1 hour in all animals. Redness was fully reversed at 24h in two animals and at 48h in the last rabbit. There were no effects on the cornea and the iris at any time point. Chemosis was not observed at any time point in all animals.
It can be concluded that BP Solvent IH/Isohexadecane would not be classified as eye irritant.
Other effects:
There were no pathological modifications on the deeper eye sections that were checked (cornea, anterior chamber, iris, vitreous body, eye background).

No additional data

Interpretation of results:
other: Not irritating
Remarks:
Migrated information
Conclusions:
under the test conditions, BP Solvent IH/Isohexadecan is not classified as eye irritant according to the criteria of Annex VI of the Directive 67/548/EEC and the CLP Regulation 1272/2008.
Executive summary:

The irritant potential of the substance BP Solvent IH/Isohexadecane was assessed by applying 0.1 mL of the test substance in the conjunctival sac of the left eye of 6 male Himalayan rabbits. After application the animals lid were kept closed for 1 second. The right eye was used as control and received 0.1 mL of physiological NaCl solution.

The eyes were examined and the changes were graded according to a numerical scale at 15 min, 1, 24, 48 and 72 hours after dosing.

No conjunctival chemosis, corneal and iridal lesion were observed throughout the observation period. Slight redness of the conjunctivae was observed in all animals at 1 hour but only in one animal by the 24 hours after instillation. At 48-hour observation period, no redness was observed in any rabbit. Hence, the mean individual score for redness was 0.33-0.0-0.0.

BP Solvent IH/Isohexadecane is not classified as eye irritant according to Annex VI of the Directive 67/548/EEC and CLP Regulation 1272/2008.

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There is limited skin irritation and no eye irritation data available for Isoeicosane. However, data is available for structural analogue isohexadecane. This data is read across to based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in IUCLID Section 13.

Skin Irritation

In a key skin irritation study (INEOS, 1980), the skin irritating properties of the test material (isohexadecane) were assessed in White Vienna rabbits (3 animals of both sexes). The test substance was applied on a wipe put in contact with the shaved skin under semi-occlusive dressing for 24 hours. At the end of exposure, skin reactions were recorded both at 24 hours (patch removal) and 48 hours after the end of exposure (i.e. 72 -hour time observation) according to the Draize scale. Complete observation time was 14 days. Moreover, the behavior, general state and food consumption were also observed. Body weight was measured every day. There was a very slight erythema (score 1) in two rabbits at patch removal (observation time = 24h). At the 72-hour observation, no erythema was observed in all 6 animals. No oedema was noted in any animal at any observation time. No systemic effect was observed following exposure to the test material. Behavior, general state, fur, food consumption and body weight development were normal. Under these test conditions, isohexadecane was not classified as a skin irritant according to CLP Regulation 1272/2008.

One reliable study was performed with human volunteers exposed to isohexadecane and isoeicosane for 24 h in occlusive conditions. Only slight signs of irritation lead to the conclusion that test substances were not skin irritants.

Ocular Irritation

In a key eye irritation study (INEOS, 1980), the irritant potential of the test material (Isohexadecane) was assessed by applying 0.1 mL of the test substance in the conjunctival sac of the left eye of 6 male Himalayan rabbits. After application the animals lid were kept closed for 1 second. The right eye was used as control and received 0.1 mL of physiological NaCl solution. The eyes were examined and the changes were graded according to a numerical scale at 15 min, 1, 24, 48 and 72 hours after dosing. No conjunctival chemosis, corneal and iridal lesion were observed throughout the observation period. Slight redness of the conjunctivae was observed in all animals at 1 hour but only in one animal by the 24 hours after instillation. At 48-hour observation period, no redness was observed in any rabbit. Hence, the mean individual score for redness was 0.33-0.0-0.0.

Isohexadecane is not classified as eye irritant according to CLP Regulation 1272/2008.

Respiratory Irritation

No studies were located to indicate that Isoeicosane is a respiratory irritant.

Justification for classification or non-classification

Skin Irritation:

Based on available read across data, Isoeicosane does not meet the criteria for classification for skin Irritation under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).

 

Ocular Irritation:

Based on available read across data, Isoeicosane does not meet the criteria for classification as ocular irritants under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).

 

Respiratory Irritation:

There are no studies that warrant classification as a respiratory irritant under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).